Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation
This trial is active, not recruiting.
|Sponsor||VZW Cardiovascular Research Center Aalst|
|Collaborator||AZ Sint-Jan AV|
|Start date||March 2014|
|End date||August 2016|
|Trial size||152 participants|
|Trial identifier||NCT02475642, POWDER-AF01|
The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Efficacy as measured by freedom of arrhythmia recurrence
time frame: 9 months
Safety as measured by drug discontinuation
time frame: 9 months
Male or female participants at least 18 years old.
- patient has continued (IC or III) ADT throughout the 3-month blanking
- patient is free of symptomatic and asymptomatic AF (as evidenced by 1-day Holter) at the 3-month visit
- drug-resistant (at least one class IC or III) symptomatic AF was the primary indication for prior PV isolation
- in the three months prior to PVI, at least one episode of symptomatic or asymptomatic AF
- PV isolation was performed according to the standards set forward by the Task Force Document (sedation or general anesthesia)
- PV isolation was the only target for ablation (except for cavotricuspid (CTI) ablation if documented AFL)
- PV isolation was performed by point-by-point irrigated radio frequency (RF) guided by contact-force (Biosense) (10-30gr-continuous lesion)
- PV isolation (i.e. entry block) was verified in each vein after a waiting time and adenosine (with continued RF if acute reconnection)
- Signed Patient Informed Consent Form.
- Age 18 years or older.
- Able and willing to comply with all follow-up testing and requirements.
- Longstanding persistent atrial fibrillation (>12 months of continuous AF)
- Previous ablation for AF
- left atrium (LA) size > 55 mm
- left ventricular ejection fraction (LVEF) < 40%
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- coronary artery bypass graft (CABG) procedure within the last six months
- Awaiting cardiac transplantation or other cardiac surgery
- Documented left atrial thrombus on imaging
- Diagnosed atrial myxoma
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Uncontrolled heart failure
- Myocardial infarction within the previous two (2) months
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- Life expectancy less than 12 months
- Enrollment in any other study evaluating another device or drug
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
- Patients not taking any class IC or III ADT at 3 months after PV isolation
- No documentation of entry block at initial PV isolation - no waiting time or adenosine.
- Additional linear ablation or defractionation during the initial procedure (except for CTI ablation for documented or induced cavo-tricuspid isthmus dependent flutter).
|Official title||Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation: A Prospective 2-Centre Randomized Controlled Clinical Study (POWDER-AF)|
|Principal investigator||Mattias Duytschaever, MD, PhD|
|Description||Subjects that underwent PV isolation for paroxysmal or non-longstanding persistent AF and are free of arrhythmia at the end of the 3-month blanking period while taking ADT. Eligible subjects who sign the study informed consent form will be randomized into one of two study arms: PVI+ADT Group: continue ADT through 9 months follow-up PVI-ADT Group: no ADT through 9 months follow up|
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