STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

Atrial Fibrillation Clinical Trial

— STARAF3  

Official title:

Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428944
• Other study ID #: MP-33-2021-2805
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 2027

Study information

• Verified date: June 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Caroline Girard
• Phone: 514-376-3330
• Email: caroline.girard[@]icm-mhi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

1. PV antral isolation alone (PVAI)

2. PV antral isolation plus ablation of drivers (PVAI+drivers)

3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 615
• Est. completion date: January 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients 18 years of age or older

2. Patients undergoing first-time ablation procedure for AF

3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years

4. Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above

5. Patients whose AF has been refractory to at least one antiarrhythmic drug

6. At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment

7. Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

1. Patients with paroxysmal AF (no episodes lasting > 7 days)

2. Patients with early persistent AF, sustained episode = 3 months

3. Patients with very long lasting persistent AF (episodes lasting > 3 years)

4. Patients with CHA2DS2-VASc score of 0.

5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued

6. Patients with AF felt to be secondary to an obvious reversible cause

7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin

8. Patients with left atrial diameter > 60 mm in the parasternal long axis view

9. Patients who are pregnant

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Standard PVI
• Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Standard PVI + Ablation of drivers in LA and RA
• Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Standard PVI + Electrical isolation of the posterior wall of the left atrium

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital and Cardiovascular Centre	Adelaide
Australia	Canberra Heart Rhythm Foundation	Garran	Australian Capital Territory
Australia	Royal Melbourne Hospital	Parkville
Austria	Medical University of Graz	Graz,
Austria	Ordensklinikum Linz GmbH	Linz
Belgium	OLV Hospital Aalst	Aalst
Belgium	Antwerp University Hospital (UZA)	Edegem
Belgium	AZ Sint-Jan	Ruddershove
Canada	University of Calgary Foothills	Calgary	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Laurent Macle	Montreal	QC - Québec
Canada	MUHC, McGill University Health Centre	Montreal	Quebec
Canada	Southlake Regional Health Center	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Quebec
Canada	Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)	Québec	Quebec
Canada	Hôpital Fleurimont, CHUS	Sherbrooke	Quebec
Canada	St. Paul's Hospital, Vancouver, BC	Vancouver	British Colombia
Canada	Vancouver General Hospital	Vancouver,	British Colombia
Canada	Royal Jubilee Hospital	Victoria	British Colombia
France	Hospital St-Joseph	Marseille
France	CHU Arnaud de Villeneuve	Montpellier
France	Institut Mutualiste Montsouris	Paris
France	Clinique Pasteur	Toulouse
France	Clinique du Tonkin	Villeurbanne
Italy	Ospedale Generale Regionale F. Miulli	Acquaviva delle Fonti
Japan	Juntendo University Hospital	Bunkyo City	Tokyo
Japan	National University Corporation Kobe University	Chuo Ku
Japan	Dokkyo Medical University Koshigaya Hospital	Koshigaya	Saitama
Japan	Jikei University School of Med	Tokyo
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	Nihon University School of Medicine	Tokyo
Spain	Hospital Clinic Barcelona	Barcelona
United States	Brigham & Women'S Hosptial Inc.	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Montreal Heart Institute

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from documented atrial arrhythmia = 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).		18 months
Secondary	Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM		18 months
Secondary	Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM		18 months
Secondary	Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM		18 months
Secondary	Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM		18 months
Secondary	Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM		18 months
Secondary	Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM		18 months
Secondary	Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM		18 months
Secondary	Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM		18 months
Secondary	Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM		18 months
Secondary	Each of the above success measures stratified by CHA2DS2-VASc score		18 months
Secondary	Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death		18 months
Secondary	Procedure duration		18 months
Secondary	Fluoroscopy time (dose)		18 months
Secondary	Radiofrequency time		18 months
Secondary	Number of repeat procedures		18 months
Secondary	Effect of each strategy on AF cycle length changes and AF termination		18 months
Secondary	Correlation of acute AF termination on long-term procedural outcome		18 months
Secondary	Quality of life measurements during follow-up using AFEQT questionnaire	AFEQT questionnaires will be used at baseline, 6, 12 and 18 months	6-12-18 months
Secondary	Quality of life measurements during follow-up using SF12 questionnaires	SF36 questionnaires will be used at baseline, 6, 12 and 18 months	6-12-18 months
Secondary	Change in AF burden post-ablation procedure (% of time in AF)		18 months