Clinical trial NCT02475642: Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: VZW Cardiovascular Research Center Aalst
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
First posted: 2015-06-19
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Efficacy as measured by freedom of arrhythmia recurrence
timeFrame: 9 months
measure: Safety as measured by drug discontinuation
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
city: Brugge
country: Belgium
facility: AZ St Jan
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Mattias Duytschaever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: