Status:
COMPLETED
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation
Lead Sponsor:
AZ Sint-Jan AV
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inef...
Detailed Description
Background: In real-life, ADT is often continued after catheter ablation for persistent AF. No study investigated whether ADT continued beyond the blanking period reduces recurrence after a first abla...
Eligibility Criteria
Inclusion
- 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).
- Before PVI, there was at least one episode of persistent AF in the last year.
- Signed Patient Informed Consent Form.
- Age 18 years or older.
- Able and willing to comply with all follow-up testing and requirements.
Exclusion
- Patients not willing or not suited to take any class IC or III ADT.
- Any prior AF episode ≥12 months, or any recurrence of AF \<3 days after cardioversion.
- 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
- BMI \>35
- Recent (\<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
- Active illness or systemic infection or sepsis
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Awaiting cardiac transplantation or other cardiac surgery
- Documented left atrial thrombus or atrial myxoma on imaging
- History of blood clotting or bleeding abnormalities
- Enrollment in any other study evaluating another device or drug
- Women with childbearing potential
- Life expectancy less than 12 months
- Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03437356
Start Date
February 26 2018
End Date
June 30 2022
Last Update
July 11 2022
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Graz
Graz, Austria
2
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Belgium
3
ZNA Middelheim
Antwerp, Belgium
4
AZ Sint-Jan Hospital
Bruges, Belgium, 8000