Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation (POWDER-AF)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: PVI-ADT; Other: PVI+ADT

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

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Hospital
  • Brugge, Belgium, 8300
    • AZ St Jan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PVI-ADT; discontinue antiarrhythmic drugs at 3 months post PVI	Other: PVI-ADT; Discontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm
ACTIVE_COMPARATOR: PVI+ADT; discontinue antiarrhythmic drugs at 12 months post PVI	Other: PVI+ADT; Discontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as measured by freedom of arrhythmia recurrence	Arrhythmia recurrence rate at 1 year post ablation (9 months post randomization)	9 months
Safety as measured by drug discontinuation	Number of participants with any adverse events at 1 year post ablation (9 months post randomization) leading to drug discontinuation	9 months

Collaborators and Investigators

• Sponsor: VZW Cardiovascular Research Center Aalst
• Collaborators: AZ Sint-Jan AV
• Investigators: Principal Investigator: Mattias Duytschaever, MD, PhD, AZ St- Jan Brugge

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2016
• Study Completion (ANTICIPATED): August 1, 2016

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (ESTIMATE): June 19, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: POWDER-AF01