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

NCT02475642 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2016-04-28

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • AZ Sint-Jan AV

    collaborator OTHER

  • VZW Cardiovascular Research Center Aalst

    lead OTHER

Principal Investigators

  • Mattias Duytschaever, MD, PhD · AZ Sint-Lucas Brugge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475642 on ClinicalTrials.gov