STrategies for Catheter Ablation of PeRsistent Atrial Fibrlllation (STARAF3)

McGill University

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI); Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers); Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

Study type: Interventional

Funder types: Other

Identifiers

NCT04428944

MP-33-2021-2805

Details and patient eligibility

About

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.

Enrollment: 617 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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617 participants in 3 patient groups

PV antral isolation alone (PVAI)

Active Comparator group

Description:

PV antral isolation alone (PVAI)

Treatment:

Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)

PV antral isolation plus ablation of drivers

Active Comparator group

Description:

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

Treatment:

Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)

PV antral isolation plus isolation of posterior wall

Active Comparator group

Description:

PV antral isolation plus isolation of LA posterior wall (PVAI+Box)

Treatment:

Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)