Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design.
Catheter ablation
Cryoablation
Cryoballoon
Persistent atrial fibrillation
Posterior wall isolation
Journal
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
ISSN: 1572-8595
Titre abrégé: J Interv Card Electrophysiol
Pays: Netherlands
ID NLM: 9708966
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
15
08
2020
accepted:
21
09
2020
pubmed:
4
10
2020
medline:
5
10
2021
entrez:
3
10
2020
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 33009645
doi: 10.1007/s10840-020-00885-w
pii: 10.1007/s10840-020-00885-w
pmc: PMC8210744
mid: NIHMS1712963
doi:
Banques de données
ClinicalTrials.gov
['NCT04505163']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
187-198Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL145017
Pays : United States
Informations de copyright
© 2020. Springer Science+Business Media, LLC, part of Springer Nature.
Références
Circ Arrhythm Electrophysiol. 2018 May;11(5):e005861
pubmed: 29700055
Heart Rhythm O2. 2020 May 28;1(3):173-179
pubmed: 34113871
J Physiol. 2003 Sep 15;551(Pt 3):801-13
pubmed: 12847206
Circ Arrhythm Electrophysiol. 2012 Oct;5(5):968-77
pubmed: 22972873
JACC Clin Electrophysiol. 2021 Feb;7(2):187-196
pubmed: 33602399
J Cardiovasc Electrophysiol. 2016 Aug;27(8):897-904
pubmed: 27120698
Heart Rhythm. 2016 Feb;13(2):424-32
pubmed: 26520204
Heart Rhythm. 2019 Sep;16(9):1392-1398
pubmed: 30885736
Heart Rhythm. 2017 Aug;14(8):1111-1118
pubmed: 28495652
Heart Rhythm. 2018 Aug;15(8):1121-1129
pubmed: 30060879
Heart Rhythm. 2017 Sep;14(9):1311-1318
pubmed: 28625928
Basic Res Cardiol. 2011 Jan;106(1):65-74
pubmed: 21072524
J Thorac Cardiovasc Surg. 1991 Mar;101(3):406-26
pubmed: 1999934
J Cardiovasc Electrophysiol. 2015 May;26(5):493-500
pubmed: 25644659
J Cardiovasc Electrophysiol. 2012 Mar;23(3):271-9
pubmed: 21954878
J Atr Fibrillation. 2017 Apr 30;9(6):1538
pubmed: 29250289
J Cardiovasc Electrophysiol. 2010 Feb;21(2):126-32
pubmed: 19804549
J Am Coll Cardiol. 2019 Jul 9;74(1):104-132
pubmed: 30703431
Circ Arrhythm Electrophysiol. 2010 Dec;3(6):606-15
pubmed: 20719881
J Interv Card Electrophysiol. 2021 Oct;62(1):161-169
pubmed: 33000358
Circ Arrhythm Electrophysiol. 2008 Apr;1(1):39-48
pubmed: 19808392
Biomed Eng Online. 2015 Feb 18;14:12
pubmed: 25886498
Curr Treat Options Cardiovasc Med. 2016 Mar;18(3):15
pubmed: 26874703
Circ J. 2017 Jan 25;81(2):172-179
pubmed: 27980294
Heart Rhythm. 2010 Jun;7(6):835-46
pubmed: 20206320
Circ Arrhythm Electrophysiol. 2012 Apr;5(2):351-60
pubmed: 22294615
J Cardiovasc Electrophysiol. 2019 Jun;30(6):805-814
pubmed: 30767365
Heart Rhythm. 2009 Aug;6(8):1109-17
pubmed: 19574109
Europace. 2017 Dec 1;19(12):1958-1966
pubmed: 28204434
Semin Thorac Cardiovasc Surg. 2000 Jan;12(1):15-9
pubmed: 10746917
Circulation. 2003 Jul 1;107(25):3176-83
pubmed: 12821558
Int J Cardiol. 2015 Feb 15;181:277-83
pubmed: 25535691
Heart Rhythm. 2016 Jan;13(1):132-40
pubmed: 26277862
Cardiol Young. 2001 Nov;11(6):632-42
pubmed: 11813915
J Am Coll Cardiol. 2012 Jul 3;60(1):54-61
pubmed: 22742400
Cryobiology. 2009 Dec;59(3):229-43
pubmed: 19833119
J Interv Card Electrophysiol. 2016 Sep;46(3):199-201
pubmed: 27184809
J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53
pubmed: 15172410
J Innov Card Rhythm Manag. 2018 Jun 15;9(6):3186-3194
pubmed: 32477812
Circ Arrhythm Electrophysiol. 2014 Feb;7(1):39-45
pubmed: 24385448
Circ Arrhythm Electrophysiol. 2010 Dec;3(6):590-9
pubmed: 20937721
Circ Arrhythm Electrophysiol. 2015 Feb;8(1):186-92
pubmed: 25532529
N Engl J Med. 1998 Sep 3;339(10):659-66
pubmed: 9725923
J Interv Card Electrophysiol. 2019 Aug;55(2):191-196
pubmed: 30734138
J Cardiovasc Electrophysiol. 2008 Mar;19(3):326-9
pubmed: 17887980
Circulation. 2003 Feb 11;107(5):733-9
pubmed: 12578877
J Interv Card Electrophysiol. 2016 Sep;46(3):267-74
pubmed: 26971331
J Am Coll Cardiol. 2013 Jul 9;62(2):138-147
pubmed: 23563126
Heart Rhythm. 2017 Sep;14(9):1319-1325
pubmed: 28625929
Mol Cell Biochem. 2008 Oct;317(1-2):69-75
pubmed: 18553177
Circulation. 2000 Jan 18;101(2):194-9
pubmed: 10637208
Dev Dyn. 2006 Jan;235(1):2-9
pubmed: 16193508