Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation (SARA)

April 25, 2013 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic Universitari
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Marañon
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Clínica Puerta de Hierro
    • Bizkaia
      • Bilbao, Bizkaia, Spain
        • Hospital de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)

Exclusion Criteria:

  • Hypo or hyperthyroidism
  • Persistent atrial fibrillation lasting more than 1 year or non-defined duration
  • Hypertrophic myocardiopathy
  • Implantable defibrillation or pacemaker implanted
  • Moderate or severe mitral valve disease or mitral prosthetic valve
  • Ejection fraction less than 30%
  • Left atrial anteroposterior diameter more than 50 mm.
  • Previous atrial fibrillation ablation
  • Contraindication to anticoagulation
  • Left atrium thrombus
  • Current infective disease or sepsis
  • Pregnant women
  • Current unstable angor
  • Acute myocardial infarction in last 3 months
  • Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
  • Reduced expectancy of life (less than 12 months)
  • Patient participating in another clinical study that investigates a drug or device
  • Psychologically unstable patient or denies to give informed consent
  • Any cause that contraindicate ablation procedure or antiarrhythmic drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atrial Fibrillation Ablation
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.
Active Comparator: Drug therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Time Frame: 1-year follow-up
1-year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
Time Frame: 1-year follow-up
1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
Time Frame: 1-year follow-up
1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions
Time Frame: 1-year follow-up
1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
Time Frame: 1-year follow-up
1-year follow-up
Change in need of cardioversions
Time Frame: From 3rd to 12th months
From 3rd to 12th months
Need of atrio-ventricular node ablation
Time Frame: 1-year follow-up
1-year follow-up
Need of crossover to the other arm of the study (only when primary end point has been reached)
Time Frame: 1-year follow-up
1-year follow-up
Need of a new intervention or ablation during blanking period
Time Frame: Until 3rd month
Until 3rd month
Detection of asymptomatic episodes by Reveal XT
Time Frame: 1-year follow-up
1-year follow-up
Presence of any complications in the acute phase or during follow-up
Time Frame: 1-year follow-up
1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Medtronic
Biosense Webster, Inc.
Fundacio Clinic Barcelona

Investigators

  • Study Chair: Lluís Mont, MD, Hospital Clinic of Barcelona
  • Study Director: Angel Arenal, MD, Hospital Gregorio Marañon
  • Study Director: Julian Villacastin, MD, Hospital San Carlos, Madrid
  • Study Director: Josep Brugada, prof Md. PHD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARA-08
  • EudraCT: 2008-006095-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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