Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation
Information source: VZW Cardiovascular Research Center Aalst
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: PVI-ADT (Other); PVI+ADT (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: VZW Cardiovascular Research Center Aalst Official(s) and/or principal investigator(s): Mattias Duytschaever, MD, PhD, Principal Investigator, Affiliation: AZ St Jan Brugge
Overall contact: Hedwig Batjoens, RN, Phone: +3253724111, Email: hedwig.batjoens@olvz-aalst.be
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy as measured by freedom of arrhythmia recurrenceSafety as measured by drug discontinuation
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Hedwig Batjoens, RN, Phone: +3253724111, Email: hedwig.batjoens@olvz-aalst.be
OLV Hospital, Aalst 9300, Belgium; Recruiting Hedwig Batjoens, RN, Phone: +3253724111 Tom JR De Potter, MD, Principal Investigator
AZ St Jan, Brugge 8300, Belgium; Recruiting Dianne Van Kats, RN, Phone: +3250453896 Mattias Duytschaever, MD, PhD, Principal Investigator
Additional Information
Starting date: March 2014
Last updated: June 15, 2015
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