Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients).

In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AZ Sint-Jan AV
• Collaborator: Biosense Webster, Inc.
• Treatments: Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

1. Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode ≥7 days (ESC 2016 guidelines).

2. Before PVI, there was at least one episode of persistent AF in the last year.

3. Signed Patient Informed Consent Form.

4. Age 18 years or older.

5. Able and willing to comply with all follow-up testing and requirements.

Exclusion Criteria:

1. Patients not willing or not suited to take any class IC or III ADT.

2. Any prior AF episode ≥12 months, or any recurrence of AF <3 days after cardioversion.

3. Presence of structural heart disease on echo criteria:

severe valvular heart disease; LA diameter >50mm; LV ejection fraction <35% (except if suspected tachycardiomyopathy); septal diameter >15mm

4. BMI >35

5. Recent (<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina

6. Active illness or systemic infection or sepsis

7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

8. Awaiting cardiac transplantation or other cardiac surgery

9. Documented left atrial thrombus or atrial myxoma on imaging

10. History of blood clotting or bleeding abnormalities

11. Enrollment in any other study evaluating another device or drug

12. Women with childbearing potential

13. Life expectancy less than 12 months

14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)