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Completed

NCT Number: NCT00863213

Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic Universitari, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrial fibrillation ablation

Procedure

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.

Antiarrhythmic drug

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.

Primary outcomes

  1. Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.

    Time frame: 1-year follow-up

Secondary outcomes

  1. Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.

    Time frame: 1-year follow-up

  2. Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.

    Time frame: 1-year follow-up

  3. Decrease in atrial fibrillation/atrial flutter related hospital admissions

    Time frame: 1-year follow-up

  4. Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.

    Time frame: 1-year follow-up

  5. Change in need of cardioversions

    Time frame: From 3rd to 12th months

  6. Need of atrio-ventricular node ablation

    Time frame: 1-year follow-up

  7. Need of crossover to the other arm of the study (only when primary end point has been reached)

    Time frame: 1-year follow-up

  8. Need of a new intervention or ablation during blanking period

    Time frame: Until 3rd month

  9. Detection of asymptomatic episodes by Reveal XT

    Time frame: 1-year follow-up

  10. Presence of any complications in the acute phase or during follow-up

    Time frame: 1-year follow-up

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Biosense Webster, Inc.
  • Fundacio Clinic Barcelona
  • Medtronic

Registry information

Acronym: SARA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 17, 2009
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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