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Strategies For Catheter Ablation of Persistent Atrial Fibrillation: A Randomized, Comparative Study-STAR AF 3

The number of patients recruited by Canberra Heart Rhythm: 1

Study Description

This is a multicenter, randomized, single blind, clinical study that will compare the efficacy of three different ablation strategies in participants with persistent atrial fibrillation (AF): (1) Pulmonary Vein (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. Up to 600 eligible participants undergoing first-time ablation to treat persistent atrial fibrillation (AF) and who signed informed consent will be enrolled from 35 to 40 high-volume, experienced ablation sites. Randomization will occur stratified by center. Participants will be randomized 1:1:1 to each of the three strategies.

Primary Objective:

To compare the three different ablation strategies in participants with persistent AF on recurrence of atrial arrhythmia after one ablation procedure:

  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)

Secondary Objectives:

  1. To compare the three different ablation strategies on:
  2. Recurrence of AF and symptomatic AF, after one procedure
  3. Recurrence of atrial arrhythmia, AF and symptomatic AF after one or more procedures
  4. Peri-procedural complications and procedural characteristics
  5. Number of repeat procedures – AF cycle length changes and AF termination
  6. AF burden
  7. Quality of life
  •  To evaluate the effect of the three ablation strategies on atrial arrhythmia, AF and symptomatic AF, stratified by CHA2DS2-VASc score and sub-type of persistent AF (≤1 year vs >1 year)
  • To assess the relationship between acute AF termination and long-term procedural outcome
  • To evaluate the correlation between AF burden and symptoms and quality of life changes
  • To compare monitoring methods used to identify AF recurrence after ablation.

Inclusion criteria:

1. Participants 18 years of age or older

2. Participants undergoing first-time ablation procedure for AF

3. Participants with persistent AF defined as a sustained episode >3 months but < 3 years

4. Participants with symptomatic AF – symptomatic participants 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. Participants whose AF has been refractory or intolerant to at least one antiarrhythmic drug

6. At least one episode of AF must have been documented by ECG, 24- hour Holter, loop recorder, telemetry, trans-telephonic monitor, or implanted device within the last 2 years from enrolment.

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

Exclusion Criteria:

  1. Participants with paroxysmal AF
  2. Participants with early persistent AF, sustained episode ≤ 3 months
  3. Participants with very long-lasting persistent AF (episodes lasting >3 years)
  4. Participants with CHA2DS2-VASc score of 0.
  5. Participants for whom cardioversion or sinus rhythm will never be attempted/pursued.
  6. Participants with AF felt to be secondary to an obvious reversible cause.
  7. Participants with contraindication to oral anticoagulation or systemic anticoagulation with heparin
  8. Participants with left atrial diameter >60 mm in the parasternal long axis view (if diameter is unavailable, volume of >100 mL or 60 mL/m2 should be considered as exclusion criteria instead)
  9. Presence of intracardiac thrombus
  10. Participants who are pregnant (assessed by participants informing the Investigators).