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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 recurrence

Safety 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

Page last updated: August 23, 2015

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