Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy
Background Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD over...
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| Veröffentlicht in: | The American heart journal 2012-05, Vol.163 (5), p.753-760.e2 |
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| creator | Olde Nordkamp, Louise R.A., MD Knops, Reinoud E., MD Bardy, Gust H., MD Blaauw, Yuri, MD, PhD Boersma, Lucas V.A., MD, PhD Bos, Johannes S., MD, PhD Delnoy, Peter Paul H.M., MD, PhD van Dessel, Pascal F.H.M., MD, PhD Driessen, Antoine H.G., MD de Groot, Joris R., MD, PhD Herrman, Jean Paul R., MD, PhD Jordaens, Luc J.L.M., MD, PhD Kooiman, Kirsten M., CCDS Maass, Alexander H., MD, PhD Meine, Mathias, MD, PhD Mizusawa, Yuka, MD Molhoek, Sander G., MD, PhD van Opstal, Jurjen, MD, PhD Tijssen, Jan G.P., PhD Wilde, Arthur A.M., MD, PhD |
| description | Background Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear. Study Design The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made. Conclusion The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022. |
| doi_str_mv | 10.1016/j.ahj.2012.02.012 |
| format | Article |
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These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear. Study Design The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made. Conclusion The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2012.02.012</identifier><identifier>PMID: 22607851</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Biological and medical sciences ; Cardiac arrhythmia ; Cardiology. Vascular system ; Cardiovascular ; Cross-Over Studies ; Death, Sudden, Cardiac - prevention & control ; Defibrillators ; Defibrillators, Implantable ; Double-Blind Method ; Electrocardiography ; Equipment Design ; Equipment Safety ; Female ; Follow-Up Studies ; Heart Arrest - mortality ; Heart Arrest - therapy ; Heart Conduction System - physiopathology ; Humans ; Male ; Medical sciences ; Mortality ; Prospective Studies ; Quality of life ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Risk Assessment ; Skin ; Survival Rate ; Tachycardia, Ventricular - diagnosis ; Tachycardia, Ventricular - mortality ; Tachycardia, Ventricular - therapy ; Treatment Outcome</subject><ispartof>The American heart journal, 2012-05, Vol.163 (5), p.753-760.e2</ispartof><rights>Mosby, Inc.</rights><rights>2012 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited May 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c575t-a4ce24f63157c140db57520f0bbccc510fc0b0ee21af61a6f1fe6db16a7167f23</citedby><cites>FETCH-LOGICAL-c575t-a4ce24f63157c140db57520f0bbccc510fc0b0ee21af61a6f1fe6db16a7167f23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870312000968$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26259998$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22607851$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Olde Nordkamp, Louise R.A., MD</creatorcontrib><creatorcontrib>Knops, Reinoud E., MD</creatorcontrib><creatorcontrib>Bardy, Gust H., MD</creatorcontrib><creatorcontrib>Blaauw, Yuri, MD, PhD</creatorcontrib><creatorcontrib>Boersma, Lucas V.A., MD, PhD</creatorcontrib><creatorcontrib>Bos, Johannes S., MD, PhD</creatorcontrib><creatorcontrib>Delnoy, Peter Paul H.M., MD, PhD</creatorcontrib><creatorcontrib>van Dessel, Pascal F.H.M., MD, PhD</creatorcontrib><creatorcontrib>Driessen, Antoine H.G., MD</creatorcontrib><creatorcontrib>de Groot, Joris R., MD, PhD</creatorcontrib><creatorcontrib>Herrman, Jean Paul R., MD, PhD</creatorcontrib><creatorcontrib>Jordaens, Luc J.L.M., MD, PhD</creatorcontrib><creatorcontrib>Kooiman, Kirsten M., CCDS</creatorcontrib><creatorcontrib>Maass, Alexander H., MD, PhD</creatorcontrib><creatorcontrib>Meine, Mathias, MD, PhD</creatorcontrib><creatorcontrib>Mizusawa, Yuka, MD</creatorcontrib><creatorcontrib>Molhoek, Sander G., MD, PhD</creatorcontrib><creatorcontrib>van Opstal, Jurjen, MD, PhD</creatorcontrib><creatorcontrib>Tijssen, Jan G.P., PhD</creatorcontrib><creatorcontrib>Wilde, Arthur A.M., MD, PhD</creatorcontrib><title>Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear. Study Design The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made. Conclusion The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022.</description><subject>Biological and medical sciences</subject><subject>Cardiac arrhythmia</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular</subject><subject>Cross-Over Studies</subject><subject>Death, Sudden, Cardiac - prevention & control</subject><subject>Defibrillators</subject><subject>Defibrillators, Implantable</subject><subject>Double-Blind Method</subject><subject>Electrocardiography</subject><subject>Equipment Design</subject><subject>Equipment Safety</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart Arrest - mortality</subject><subject>Heart Arrest - therapy</subject><subject>Heart Conduction System - physiopathology</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mortality</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Risk Assessment</subject><subject>Skin</subject><subject>Survival Rate</subject><subject>Tachycardia, Ventricular - diagnosis</subject><subject>Tachycardia, Ventricular - mortality</subject><subject>Tachycardia, Ventricular - therapy</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kt-K1DAUxoso7rj6AN5IQQQv7JikbdpZQSjLqAPLzjKO1yVNTtyMbVKTdmB8G9_U053Rhb0QDuQPv-_LyTknil5SMqeE8ve7ubjdzRmhbE4wKHsUzShZFAkvsuxxNCOEsKQsSHoWPQthh0fOSv40OmOMk6LM6Sz6vRGDcVa0EAurYgXBfLex0_FwC_HNplpu15tVdR0P3oj2Iq7iG-9CD3Iwe3gXbyqrXGd-LVUsXdcLb4K7U4exkeNWWFiP4c542Agb9mAdnldd31bXg2jwUSm8Mm4PfgCfKNCm8aZtxeD8lIEX_eF59ESLNsCL03oeffu03F5-Sa7Wn1eX1VUi8yIfEpFJYJnmKc0LSTOiGrxmRJOmkVLmlGhJGgLAqNCcCq6pBq4aykVBeaFZeh69Pfr23v0cIQx1Z4IETMYCZl1jxXOWFWWWIvr6Abpzo8ciIpWTjKdFnk-G9EhJLFnwoOvem074A1pNbrze1di_eupfTTDopHl1ch6bDtQ_xd-GIfDmBIggRau9sNKEe46zfLFYlMh9OHKAJdsb8HWQBqwEZTx2r1bO_DeNjw_UsjXW4IM_4ADh_rd1QEH9dRq0ac4ow92Cl-kfuezOSA</recordid><startdate>20120501</startdate><enddate>20120501</enddate><creator>Olde Nordkamp, Louise R.A., MD</creator><creator>Knops, Reinoud E., MD</creator><creator>Bardy, Gust H., MD</creator><creator>Blaauw, Yuri, MD, PhD</creator><creator>Boersma, Lucas V.A., MD, PhD</creator><creator>Bos, Johannes S., MD, PhD</creator><creator>Delnoy, Peter Paul H.M., MD, PhD</creator><creator>van Dessel, Pascal F.H.M., MD, PhD</creator><creator>Driessen, Antoine H.G., MD</creator><creator>de Groot, Joris R., MD, PhD</creator><creator>Herrman, Jean Paul R., MD, PhD</creator><creator>Jordaens, Luc J.L.M., MD, PhD</creator><creator>Kooiman, Kirsten M., CCDS</creator><creator>Maass, Alexander H., MD, PhD</creator><creator>Meine, Mathias, MD, PhD</creator><creator>Mizusawa, Yuka, MD</creator><creator>Molhoek, Sander G., MD, PhD</creator><creator>van Opstal, Jurjen, MD, PhD</creator><creator>Tijssen, Jan G.P., PhD</creator><creator>Wilde, Arthur A.M., MD, PhD</creator><general>Elsevier Inc</general><general>Mosby</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20120501</creationdate><title>Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy</title><author>Olde Nordkamp, Louise R.A., MD ; Knops, Reinoud E., MD ; Bardy, Gust H., MD ; Blaauw, Yuri, MD, PhD ; Boersma, Lucas V.A., MD, PhD ; Bos, Johannes S., MD, PhD ; Delnoy, Peter Paul H.M., MD, PhD ; van Dessel, Pascal F.H.M., MD, PhD ; Driessen, Antoine H.G., MD ; de Groot, Joris R., MD, PhD ; Herrman, Jean Paul R., MD, PhD ; Jordaens, Luc J.L.M., MD, PhD ; Kooiman, Kirsten M., CCDS ; Maass, Alexander H., MD, PhD ; Meine, Mathias, MD, PhD ; Mizusawa, Yuka, MD ; Molhoek, Sander G., MD, PhD ; van Opstal, Jurjen, MD, PhD ; Tijssen, Jan G.P., PhD ; Wilde, Arthur A.M., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c575t-a4ce24f63157c140db57520f0bbccc510fc0b0ee21af61a6f1fe6db16a7167f23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Biological and medical sciences</topic><topic>Cardiac arrhythmia</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular</topic><topic>Cross-Over Studies</topic><topic>Death, Sudden, Cardiac - prevention & control</topic><topic>Defibrillators</topic><topic>Defibrillators, Implantable</topic><topic>Double-Blind Method</topic><topic>Electrocardiography</topic><topic>Equipment Design</topic><topic>Equipment Safety</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart Arrest - mortality</topic><topic>Heart Arrest - therapy</topic><topic>Heart Conduction System - physiopathology</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mortality</topic><topic>Prospective Studies</topic><topic>Quality of life</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Risk Assessment</topic><topic>Skin</topic><topic>Survival Rate</topic><topic>Tachycardia, Ventricular - diagnosis</topic><topic>Tachycardia, Ventricular - mortality</topic><topic>Tachycardia, Ventricular - therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Olde Nordkamp, Louise R.A., MD</creatorcontrib><creatorcontrib>Knops, Reinoud E., MD</creatorcontrib><creatorcontrib>Bardy, Gust H., MD</creatorcontrib><creatorcontrib>Blaauw, Yuri, MD, PhD</creatorcontrib><creatorcontrib>Boersma, Lucas V.A., MD, PhD</creatorcontrib><creatorcontrib>Bos, Johannes S., MD, PhD</creatorcontrib><creatorcontrib>Delnoy, Peter Paul H.M., MD, PhD</creatorcontrib><creatorcontrib>van Dessel, Pascal F.H.M., MD, PhD</creatorcontrib><creatorcontrib>Driessen, Antoine H.G., MD</creatorcontrib><creatorcontrib>de Groot, Joris R., MD, PhD</creatorcontrib><creatorcontrib>Herrman, Jean Paul R., MD, PhD</creatorcontrib><creatorcontrib>Jordaens, Luc J.L.M., MD, PhD</creatorcontrib><creatorcontrib>Kooiman, Kirsten M., CCDS</creatorcontrib><creatorcontrib>Maass, Alexander H., MD, PhD</creatorcontrib><creatorcontrib>Meine, Mathias, MD, PhD</creatorcontrib><creatorcontrib>Mizusawa, Yuka, MD</creatorcontrib><creatorcontrib>Molhoek, Sander G., MD, PhD</creatorcontrib><creatorcontrib>van Opstal, Jurjen, MD, PhD</creatorcontrib><creatorcontrib>Tijssen, Jan G.P., PhD</creatorcontrib><creatorcontrib>Wilde, Arthur A.M., MD, PhD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Olde Nordkamp, Louise R.A., MD</au><au>Knops, Reinoud E., MD</au><au>Bardy, Gust H., MD</au><au>Blaauw, Yuri, MD, PhD</au><au>Boersma, Lucas V.A., MD, PhD</au><au>Bos, Johannes S., MD, PhD</au><au>Delnoy, Peter Paul H.M., MD, PhD</au><au>van Dessel, Pascal F.H.M., MD, PhD</au><au>Driessen, Antoine H.G., MD</au><au>de Groot, Joris R., MD, PhD</au><au>Herrman, Jean Paul R., MD, PhD</au><au>Jordaens, Luc J.L.M., MD, PhD</au><au>Kooiman, Kirsten M., CCDS</au><au>Maass, Alexander H., MD, PhD</au><au>Meine, Mathias, MD, PhD</au><au>Mizusawa, Yuka, MD</au><au>Molhoek, Sander G., MD, PhD</au><au>van Opstal, Jurjen, MD, PhD</au><au>Tijssen, Jan G.P., PhD</au><au>Wilde, Arthur A.M., MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>163</volume><issue>5</issue><spage>753</spage><epage>760.e2</epage><pages>753-760.e2</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear. Study Design The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made. Conclusion The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>22607851</pmid><doi>10.1016/j.ahj.2012.02.012</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2012-05, Vol.163 (5), p.753-760.e2 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1015247843 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Biological and medical sciences Cardiac arrhythmia Cardiology. Vascular system Cardiovascular Cross-Over Studies Death, Sudden, Cardiac - prevention & control Defibrillators Defibrillators, Implantable Double-Blind Method Electrocardiography Equipment Design Equipment Safety Female Follow-Up Studies Heart Arrest - mortality Heart Arrest - therapy Heart Conduction System - physiopathology Humans Male Medical sciences Mortality Prospective Studies Quality of life Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Risk Assessment Skin Survival Rate Tachycardia, Ventricular - diagnosis Tachycardia, Ventricular - mortality Tachycardia, Ventricular - therapy Treatment Outcome |
| title | Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy |
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