Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation

NCT02475642 | Unknown Phase 4

• 1 other identifier: POWDER-AF01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

PVI-ADT

ACTIVE COMPARATOR

discontinue antiarrhythmic drugs at 3 months post PVI

Other: PVI-ADT

PVI+ADT

ACTIVE COMPARATOR

discontinue antiarrhythmic drugs at 12 months post PVI

Other: PVI+ADT

Interventions

PVI+ADT OTHER

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

PVI+ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst: lead
• AZ Sint-Jan AV: collaborator

Study Sites (2)

OLV Hospital

Aalst, 9300, Belgium

Location

AZ St Jan

Bruges, 8300, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mattias Duytschaever, MD, PhD

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 19, 2015
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

BE (2)