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

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Other: PVI-ADT; Other: PVI+ADT

• Registration Number: NCT02475642
• Lead Sponsor: VZW Cardiovascular Research Center Aalst

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-19
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI-ADT	PVI-ADT	discontinue antiarrhythmic drugs at 3 months post PVI
PVI+ADT	PVI+ADT	discontinue antiarrhythmic drugs at 12 months post PVI

Primary Outcome Measures

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

Trial Locations

Locations (2)

OLV Hospital; 🇧🇪 Aalst, Belgium

AZ St Jan; 🇧🇪 Brugge, Belgium