Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

NCT05264831 | Recruiting

• 2 other identifiers: PACIFIC2021-A02291-40
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 13

Brief Summary

This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then:

• Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.
• Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:
• PVI procedure alone
• PVI procedure combined with substrate modulation

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 1-year sinus rhythm maintenance rate

  Rate of patients with sinus rhythm (yes/no) at 1 year after a single ablative procedure

  At 1 year after ablation

Secondary Outcomes (13)

• Rate of patients with sinus rhythm (randomized patients)

  At 1 year after ablation

• Rate of patients with sinus rhythm (registry patients)

  At 1 year after ablation

• Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone)

  At 1 year after ablation

• Duration (in minutes) of ablative procedure

  On the day of the ablative procedure

• Duration (in minutes) of radiofrequency use

  On the day of the ablative procedure

Study Arms (2)

PVI procedure alone

ACTIVE COMPARATOR

If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to : \- Group 1: PVI procedure alone in accordance with ESC recommendations

Procedure: Pulmonary Vein Isolation (PVI) alone

PVI procedure combined with substrate modulation

EXPERIMENTAL

If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to : \- Group 2: PVI procedure associated with substrate modulation

Procedure: PVI procedure associated with substrate modulation

Interventions

Pulmonary Vein Isolation (PVI) alone PROCEDURE

PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.

PVI procedure alone

PVI procedure associated with substrate modulation PROCEDURE

PVI procedure associated with substrate modulation

PVI procedure combined with substrate modulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria to be validated for patients included before performing electric cardioversion:
• \) Persistent AF (continuous for at least 7 days without interruption according to information transmitted by the cardiologist and the patient), symptomatic and resistant to at leat one anti-arrhythmic drug treatment including amiodarone;
• Criteria to be validated for patients included after performing electric cardioversion :
• Patient treated by electric cardioversion for persistent AF, symptomatic and resistant to anti-arrhythmic treatment including amiodarone and whom ablative procedure is planned in the following 4-6 weeks after electric cardioversion
• Criteria to be validated for all patients included:
• Life expectancy \> 5 years;
• Female or male between 18 and 80 years of age at the electric cardioversion time
• Affiliation to a health insurance system;
• Patient informed of the study and having signed informed consent
• Criteria to be validated prior to randomization on the day of ablation (these patients may be randomized):
• Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.

You may not qualify if:

• Criteria to be validated before or after performing electric cardioversion (the study cannot be proposed to patients corresponding to these criteria):
• Current hyperthyroidism;
• Pregnant or breastfeeding woman;
• Patient with a Body Mass Index (BMI) greater than 35;
• Patient with severe Chronic Obstructive Pulmonary Disease (COPD);
• Patient with hypertrophic heart disease;
• Patient with a mechanical or biological mitral valve;
• Contraindications to anticoagulants;
• Transient Ischemic Attack (TIA) /stroke less than 6 months old;
• Psychiatric illness affecting follow-up;
• Left Ventricular Ejection Fraction (LVEF) \< 40% ;
• Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
• Patients under legal protection
• Cardiac surgery on left atrium
• Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)

Sponsors & Collaborators

• Elsan: lead

Study Sites (13)

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

RECRUITING

CH Libourne

Libourne, 33500, France

NOT YET RECRUITING

CHU Lille

Lille, 59000, France

ACTIVE NOT RECRUITING

Hopital ST Phillbert

Lomme, 59462, France

NOT YET RECRUITING

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, 92200, France

NOT YET RECRUITING

Hôpital Privé Les Franciscaines

Nîmes, 30000, France

RECRUITING

Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie

Paris, 75015, France

RECRUITING

Clinique St Pierre Cardiologie

Perpignan, 66000, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

CCN

Saint-Denis, 93200, France

NOT YET RECRUITING

Clinique Rhéna

Strasbourg, 67000, France

NOT YET RECRUITING

Clinique Pasteur Service de cardiologie/rythmologie

Toulouse, 31076, France

RECRUITING

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

Related Publications (14)

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Oct 21;42(40):4194. doi: 10.1093/eurheartj/ehab648. No abstract available.

  PMID: 34520521 BACKGROUND

• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 BACKGROUND

• Sanders P, Hocini M, Jais P, Sacher F, Hsu LF, Takahashi Y, Rotter M, Rostock T, Nalliah CJ, Clementy J, Haissaguerre M. Complete isolation of the pulmonary veins and posterior left atrium in chronic atrial fibrillation. Long-term clinical outcome. Eur Heart J. 2007 Aug;28(15):1862-71. doi: 10.1093/eurheartj/ehl548.

  PMID: 17341503 BACKGROUND

• Knecht S, Hocini M, Wright M, Lellouche N, O'Neill MD, Matsuo S, Nault I, Chauhan VS, Makati KJ, Bevilacqua M, Lim KT, Sacher F, Deplagne A, Derval N, Bordachar P, Jais P, Clementy J, Haissaguerre M. Left atrial linear lesions are required for successful treatment of persistent atrial fibrillation. Eur Heart J. 2008 Oct;29(19):2359-66. doi: 10.1093/eurheartj/ehn302. Epub 2008 Jul 8.

  PMID: 18614522 BACKGROUND

• Valderrabano M, Peterson LE, Bunge R, Prystash M, Dave AS, Nagueh S, Kleiman NS. Vein of Marshall ethanol infusion for persistent atrial fibrillation: VENUS and MARS clinical trial design. Am Heart J. 2019 Sep;215:52-61. doi: 10.1016/j.ahj.2019.04.022. Epub 2019 May 11.

  PMID: 31279972 BACKGROUND

• Kim DT, Lai AC, Hwang C, Fan LT, Karagueuzian HS, Chen PS, Fishbein MC. The ligament of Marshall: a structural analysis in human hearts with implications for atrial arrhythmias. J Am Coll Cardiol. 2000 Oct;36(4):1324-7. doi: 10.1016/s0735-1097(00)00819-6.

  PMID: 11028490 BACKGROUND

• Valderrabano M, Chen HR, Sidhu J, Rao L, Ling Y, Khoury DS. Retrograde ethanol infusion in the vein of Marshall: regional left atrial ablation, vagal denervation and feasibility in humans. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):50-6. doi: 10.1161/CIRCEP.108.818427.

  PMID: 19756206 BACKGROUND

• Dave AS, Baez-Escudero JL, Sasaridis C, Hong TE, Rami T, Valderrabano M. Role of the vein of Marshall in atrial fibrillation recurrences after catheter ablation: therapeutic effect of ethanol infusion. J Cardiovasc Electrophysiol. 2012 Jun;23(6):583-91. doi: 10.1111/j.1540-8167.2011.02268.x. Epub 2012 Mar 19.

  PMID: 22429895 BACKGROUND

• Pambrun T, Denis A, Duchateau J, Sacher F, Hocini M, Jais P, Haissaguerre M, Derval N. MARSHALL bundles elimination, Pulmonary veins isolation and Lines completion for ANatomical ablation of persistent atrial fibrillation: MARSHALL-PLAN case series. J Cardiovasc Electrophysiol. 2019 Jan;30(1):7-15. doi: 10.1111/jce.13797. Epub 2018 Dec 21.

  PMID: 30461121 RESULT

• Rivard L, Hocini M, Rostock T, Cauchemez B, Forclaz A, Jadidi AS, Linton N, Nault I, Miyazaki S, Liu X, Xhaet O, Shah A, Sacher F, Derval N, Jais P, Khairy P, Macle L, Nattel S, Willems S, Haissaguerre M. Improved outcome following restoration of sinus rhythm prior to catheter ablation of persistent atrial fibrillation: a comparative multicenter study. Heart Rhythm. 2012 Jul;9(7):1025-30. doi: 10.1016/j.hrthm.2012.02.016. Epub 2012 Feb 15.

  PMID: 22342863 RESULT

• Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K, Noelker G, Deharo JC, Andrikopoulos G, Dahme T, Lellouche N, Defaye P. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol. 2018 Nov;4(11):1440-1447. doi: 10.1016/j.jacep.2018.07.007. Epub 2018 Aug 25.

  PMID: 30466850 RESULT

• Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

  PMID: 32590151 RESULT

• Derval N, Duchateau J, Denis A, Ramirez FD, Mahida S, Andre C, Krisai P, Nakatani Y, Kitamura T, Takigawa M, Chauvel R, Tixier R, Pillois X, Sacher F, Hocini M, Haissaguerre M, Jais P, Pambrun T. Marshall bundle elimination, Pulmonary vein isolation, and Line completion for ANatomical ablation of persistent atrial fibrillation (Marshall-PLAN): Prospective, single-center study. Heart Rhythm. 2021 Apr;18(4):529-537. doi: 10.1016/j.hrthm.2020.12.023. Epub 2020 Dec 29.

  PMID: 33383226 RESULT

• Bortone AA, Marijon E, Limite LR, Lagrange P, Brigadeau F, Martins R, Durand C, Albenque JP; PACIFIC study group. Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design. J Cardiovasc Electrophysiol. 2023 Feb;34(2):270-278. doi: 10.1111/jce.15761. Epub 2022 Dec 7.

  PMID: 36434797 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Single Person

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Augustin Bortone, MD

  Elsan

  STUDY DIRECTOR

Central Study Contacts

Agustín Bortone, MD

CONTACT

04 66 26 63 75; agubene@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A, open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study procedure is the electric cardioversion as a discriminant factor between patients requiring PVI procedure alone or PVI procedure combined with substrate modulation. This electric cardioversion will be performed in all included patients up to 6 weeks before the ablative procedure. On the day of the ablative procedure: * If the patient presents with a Sinus Rhythm (= successful electric cardioversion, approximately 70% of patients) the patient will be treated as per SoC in accordance with ESC recommendations. It is recommended to perform PVI procedure alone in these patients. A prospective registry for these patients will be established for this study. * If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to the 2 strategies: * Group 1: PVI procedure alone in accordance with ESC recommendations * Group 2: PVI procedure associated with substrate modulation

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 3, 2022
• Study Start: February 20, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FR (13)