MedTrace Logo

Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

NCT00863213 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2013-04-26

No results posted yet for this study

Summary

The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.

Conditions

Interventions

PROCEDURE

Atrial fibrillation ablation

Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used. It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.

DRUG

Antiarrhythmic drug

Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Fundacio Clinic Barcelona

    collaborator OTHER

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Lluís Mont, MD · Hospital Clinic of Barcelona

  • Angel Arenal, MD · Hospital Gregorio Marañon

  • Julian Villacastin, MD · Hospital San Carlos, Madrid

  • Josep Brugada, prof Md. PHD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-03-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00863213 on ClinicalTrials.gov