Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design
Background There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using t...
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Veröffentlicht in: | Journal of interventional cardiac electrophysiology 2021-10, Vol.62 (1), p.187-198 |
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creator | Aryana, Arash Pujara, Deep K. Allen, Shelley L. Baker, James H. Espinosa, Martin A. Buch, Eric F. Srivatsa, Uma Ellis, Ethan Makati, Kevin Kowalski, Marcin Lee, Sung Tadros, Thomas Baykaner, Tina Al-Ahmad, Amin d’Avila, André Di Biase, Luigi Okishige, Kaoru Natale, Andrea |
description | Background
There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon.
Objective
The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF.
Methods
The PIVoTAL is a prospective, randomized controlled study (
ClinicalTrials.gov
: NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (
n
= 183) versus PVI+PWI (
n
= 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation.
Conclusion
The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence. |
doi_str_mv | 10.1007/s10840-020-00885-w |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8210744</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2577917290</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-2751a92300d2731339762b6238df1b614323d5f80c5736aba5fd1787490596273</originalsourceid><addsrcrecordid>eNp9ks1u1DAUhSMEoqXwAiyQJTZlEfBv7LBAqiqglUYqi4LYWU7iTD1K7GA7Hc2j8XbczkynhQULyz_3u-f6SKcoXhP8nmAsPySCFcclprCwUqJcPymOiZC0VKIWT-HMFCuVFD-PihcprTDGNabV8-KIMThWXBwXvxe2z8jk6MyAppCyjS5EtDbDgFwKg8kueOQ8aoNfzb7dXtcu36BpHsbgTdygWwv1B3hOzi9RGzehAZUALz0o5mhNHq3PKPRosjE5mOUPo3vXRDfsFU6_Xf4I12eLdx9RynO3QXH7bgaLjO9QZ5Nb-pfFs94Myb7a7yfF9y-fr88vysXV18vzs0XZcslzSaUgpqZguKOSEcZqWdGmokx1PWkqwhllnegVboVklWmM6DsileQ1FnUFLSfFp53uNDej7Vr4dDSDnqIbwbwOxum_K97d6GW41YoSLDkHgdO9QAy_ZpuyHl1qLZj1NsxJU84VJ5RRDOjbf9BVmCMYB0pIWRNJ6zuK7qg2hpSi7Q-fIVjfJUPvkqEhGXqbDL2GpjePbRxa7qMAANsBCUp-aePD7P_I_gGDi8jW</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2577917290</pqid></control><display><type>article</type><title>Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Aryana, Arash ; Pujara, Deep K. ; Allen, Shelley L. ; Baker, James H. ; Espinosa, Martin A. ; Buch, Eric F. ; Srivatsa, Uma ; Ellis, Ethan ; Makati, Kevin ; Kowalski, Marcin ; Lee, Sung ; Tadros, Thomas ; Baykaner, Tina ; Al-Ahmad, Amin ; d’Avila, André ; Di Biase, Luigi ; Okishige, Kaoru ; Natale, Andrea</creator><creatorcontrib>Aryana, Arash ; Pujara, Deep K. ; Allen, Shelley L. ; Baker, James H. ; Espinosa, Martin A. ; Buch, Eric F. ; Srivatsa, Uma ; Ellis, Ethan ; Makati, Kevin ; Kowalski, Marcin ; Lee, Sung ; Tadros, Thomas ; Baykaner, Tina ; Al-Ahmad, Amin ; d’Avila, André ; Di Biase, Luigi ; Okishige, Kaoru ; Natale, Andrea</creatorcontrib><description>Background
There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon.
Objective
The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF.
Methods
The PIVoTAL is a prospective, randomized controlled study (
ClinicalTrials.gov
: NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (
n
= 183) versus PVI+PWI (
n
= 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation.
Conclusion
The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.</description><identifier>ISSN: 1383-875X</identifier><identifier>EISSN: 1572-8595</identifier><identifier>DOI: 10.1007/s10840-020-00885-w</identifier><identifier>PMID: 33009645</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Ablation ; Algorithms ; Arrhythmia ; Atrial Fibrillation - diagnostic imaging ; Atrial Fibrillation - surgery ; Blanking ; Cardiac arrhythmia ; Cardiology ; Catheter Ablation ; Catheters ; Cryosurgery ; Design ; Electrocardiography ; Evaluation ; Fibrillation ; Humans ; Medical instruments ; Medicine ; Medicine & Public Health ; Patients ; Prospective Studies ; Pulmonary Veins - diagnostic imaging ; Pulmonary Veins - surgery ; Randomization ; Recurrence ; Single-Blind Method ; Treatment Outcome</subject><ispartof>Journal of interventional cardiac electrophysiology, 2021-10, Vol.62 (1), p.187-198</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020</rights><rights>2020. Springer Science+Business Media, LLC, part of Springer Nature.</rights><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-2751a92300d2731339762b6238df1b614323d5f80c5736aba5fd1787490596273</citedby><cites>FETCH-LOGICAL-c474t-2751a92300d2731339762b6238df1b614323d5f80c5736aba5fd1787490596273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10840-020-00885-w$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10840-020-00885-w$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33009645$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Aryana, Arash</creatorcontrib><creatorcontrib>Pujara, Deep K.</creatorcontrib><creatorcontrib>Allen, Shelley L.</creatorcontrib><creatorcontrib>Baker, James H.</creatorcontrib><creatorcontrib>Espinosa, Martin A.</creatorcontrib><creatorcontrib>Buch, Eric F.</creatorcontrib><creatorcontrib>Srivatsa, Uma</creatorcontrib><creatorcontrib>Ellis, Ethan</creatorcontrib><creatorcontrib>Makati, Kevin</creatorcontrib><creatorcontrib>Kowalski, Marcin</creatorcontrib><creatorcontrib>Lee, Sung</creatorcontrib><creatorcontrib>Tadros, Thomas</creatorcontrib><creatorcontrib>Baykaner, Tina</creatorcontrib><creatorcontrib>Al-Ahmad, Amin</creatorcontrib><creatorcontrib>d’Avila, André</creatorcontrib><creatorcontrib>Di Biase, Luigi</creatorcontrib><creatorcontrib>Okishige, Kaoru</creatorcontrib><creatorcontrib>Natale, Andrea</creatorcontrib><title>Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design</title><title>Journal of interventional cardiac electrophysiology</title><addtitle>J Interv Card Electrophysiol</addtitle><addtitle>J Interv Card Electrophysiol</addtitle><description>Background
There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon.
Objective
The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF.
Methods
The PIVoTAL is a prospective, randomized controlled study (
ClinicalTrials.gov
: NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (
n
= 183) versus PVI+PWI (
n
= 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation.
Conclusion
The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.</description><subject>Ablation</subject><subject>Algorithms</subject><subject>Arrhythmia</subject><subject>Atrial Fibrillation - diagnostic imaging</subject><subject>Atrial Fibrillation - surgery</subject><subject>Blanking</subject><subject>Cardiac arrhythmia</subject><subject>Cardiology</subject><subject>Catheter Ablation</subject><subject>Catheters</subject><subject>Cryosurgery</subject><subject>Design</subject><subject>Electrocardiography</subject><subject>Evaluation</subject><subject>Fibrillation</subject><subject>Humans</subject><subject>Medical instruments</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Pulmonary Veins - diagnostic imaging</subject><subject>Pulmonary Veins - surgery</subject><subject>Randomization</subject><subject>Recurrence</subject><subject>Single-Blind Method</subject><subject>Treatment Outcome</subject><issn>1383-875X</issn><issn>1572-8595</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9ks1u1DAUhSMEoqXwAiyQJTZlEfBv7LBAqiqglUYqi4LYWU7iTD1K7GA7Hc2j8XbczkynhQULyz_3u-f6SKcoXhP8nmAsPySCFcclprCwUqJcPymOiZC0VKIWT-HMFCuVFD-PihcprTDGNabV8-KIMThWXBwXvxe2z8jk6MyAppCyjS5EtDbDgFwKg8kueOQ8aoNfzb7dXtcu36BpHsbgTdygWwv1B3hOzi9RGzehAZUALz0o5mhNHq3PKPRosjE5mOUPo3vXRDfsFU6_Xf4I12eLdx9RynO3QXH7bgaLjO9QZ5Nb-pfFs94Myb7a7yfF9y-fr88vysXV18vzs0XZcslzSaUgpqZguKOSEcZqWdGmokx1PWkqwhllnegVboVklWmM6DsileQ1FnUFLSfFp53uNDej7Vr4dDSDnqIbwbwOxum_K97d6GW41YoSLDkHgdO9QAy_ZpuyHl1qLZj1NsxJU84VJ5RRDOjbf9BVmCMYB0pIWRNJ6zuK7qg2hpSi7Q-fIVjfJUPvkqEhGXqbDL2GpjePbRxa7qMAANsBCUp-aePD7P_I_gGDi8jW</recordid><startdate>20211001</startdate><enddate>20211001</enddate><creator>Aryana, Arash</creator><creator>Pujara, Deep K.</creator><creator>Allen, Shelley L.</creator><creator>Baker, James H.</creator><creator>Espinosa, Martin A.</creator><creator>Buch, Eric F.</creator><creator>Srivatsa, Uma</creator><creator>Ellis, Ethan</creator><creator>Makati, Kevin</creator><creator>Kowalski, Marcin</creator><creator>Lee, Sung</creator><creator>Tadros, Thomas</creator><creator>Baykaner, Tina</creator><creator>Al-Ahmad, Amin</creator><creator>d’Avila, André</creator><creator>Di Biase, Luigi</creator><creator>Okishige, Kaoru</creator><creator>Natale, Andrea</creator><general>Springer US</general><general>Springer Nature B.V</general><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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20211001</creationdate><title>Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design</title><author>Aryana, Arash ; Pujara, Deep K. ; Allen, Shelley L. ; Baker, James H. ; Espinosa, Martin A. ; Buch, Eric F. ; Srivatsa, Uma ; Ellis, Ethan ; Makati, Kevin ; Kowalski, Marcin ; Lee, Sung ; Tadros, Thomas ; Baykaner, Tina ; Al-Ahmad, Amin ; d’Avila, André ; Di Biase, Luigi ; Okishige, Kaoru ; Natale, Andrea</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-2751a92300d2731339762b6238df1b614323d5f80c5736aba5fd1787490596273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Ablation</topic><topic>Algorithms</topic><topic>Arrhythmia</topic><topic>Atrial Fibrillation - diagnostic imaging</topic><topic>Atrial Fibrillation - surgery</topic><topic>Blanking</topic><topic>Cardiac arrhythmia</topic><topic>Cardiology</topic><topic>Catheter Ablation</topic><topic>Catheters</topic><topic>Cryosurgery</topic><topic>Design</topic><topic>Electrocardiography</topic><topic>Evaluation</topic><topic>Fibrillation</topic><topic>Humans</topic><topic>Medical instruments</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Pulmonary Veins - diagnostic imaging</topic><topic>Pulmonary Veins - surgery</topic><topic>Randomization</topic><topic>Recurrence</topic><topic>Single-Blind Method</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Aryana, Arash</creatorcontrib><creatorcontrib>Pujara, Deep K.</creatorcontrib><creatorcontrib>Allen, Shelley L.</creatorcontrib><creatorcontrib>Baker, James H.</creatorcontrib><creatorcontrib>Espinosa, Martin A.</creatorcontrib><creatorcontrib>Buch, Eric F.</creatorcontrib><creatorcontrib>Srivatsa, Uma</creatorcontrib><creatorcontrib>Ellis, Ethan</creatorcontrib><creatorcontrib>Makati, Kevin</creatorcontrib><creatorcontrib>Kowalski, Marcin</creatorcontrib><creatorcontrib>Lee, Sung</creatorcontrib><creatorcontrib>Tadros, Thomas</creatorcontrib><creatorcontrib>Baykaner, Tina</creatorcontrib><creatorcontrib>Al-Ahmad, Amin</creatorcontrib><creatorcontrib>d’Avila, André</creatorcontrib><creatorcontrib>Di Biase, Luigi</creatorcontrib><creatorcontrib>Okishige, Kaoru</creatorcontrib><creatorcontrib>Natale, Andrea</creatorcontrib><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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</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>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of interventional cardiac electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Aryana, Arash</au><au>Pujara, Deep K.</au><au>Allen, Shelley L.</au><au>Baker, James H.</au><au>Espinosa, Martin A.</au><au>Buch, Eric F.</au><au>Srivatsa, Uma</au><au>Ellis, Ethan</au><au>Makati, Kevin</au><au>Kowalski, Marcin</au><au>Lee, Sung</au><au>Tadros, Thomas</au><au>Baykaner, Tina</au><au>Al-Ahmad, Amin</au><au>d’Avila, André</au><au>Di Biase, Luigi</au><au>Okishige, Kaoru</au><au>Natale, Andrea</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design</atitle><jtitle>Journal of interventional cardiac electrophysiology</jtitle><stitle>J Interv Card Electrophysiol</stitle><addtitle>J Interv Card Electrophysiol</addtitle><date>2021-10-01</date><risdate>2021</risdate><volume>62</volume><issue>1</issue><spage>187</spage><epage>198</epage><pages>187-198</pages><issn>1383-875X</issn><eissn>1572-8595</eissn><abstract>Background
There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon.
Objective
The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF.
Methods
The PIVoTAL is a prospective, randomized controlled study (
ClinicalTrials.gov
: NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (
n
= 183) versus PVI+PWI (
n
= 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation.
Conclusion
The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>33009645</pmid><doi>10.1007/s10840-020-00885-w</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Ablation Algorithms Arrhythmia Atrial Fibrillation - diagnostic imaging Atrial Fibrillation - surgery Blanking Cardiac arrhythmia Cardiology Catheter Ablation Catheters Cryosurgery Design Electrocardiography Evaluation Fibrillation Humans Medical instruments Medicine Medicine & Public Health Patients Prospective Studies Pulmonary Veins - diagnostic imaging Pulmonary Veins - surgery Randomization Recurrence Single-Blind Method Treatment Outcome |
title | Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design |
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