Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Fundacio Clinic
Biosense Webster, Inc.
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00863213
First received: March 16, 2009
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Procedure: Atrial fibrillation ablation
Drug: Antiarrhythmic drug
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Decrease in atrial fibrillation/atrial flutter related hospital admissions [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Change in need of cardioversions [ Time Frame: From 3rd to 12th months ] [ Designated as safety issue: No ]
  • Need of atrio-ventricular node ablation [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Need of crossover to the other arm of the study (only when primary end point has been reached) [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Need of a new intervention or ablation during blanking period [ Time Frame: Until 3rd month ] [ Designated as safety issue: No ]
  • Detection of asymptomatic episodes by Reveal XT [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Presence of any complications in the acute phase or during follow-up [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863213

Locations
Spain
Hospital de Cruces
Bilbao, Bizkaia, Spain
Hospital Clinic Universitari
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain
Clínica Puerta de Hierro
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Medtronic
Fundacio Clinic
Biosense Webster, Inc.
Investigators
Study Chair: Lluís Mont, MD Hospital Clinic de Barcelona
Study Director: Angel Arenal, MD Hospital Gregorio Marañon
Study Director: Julian Villacastin, MD Hospital Clínico San Carlos
Study Director: Josep Brugada, prof Md. PHD Hospital Clínic de Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josep Lluis Mont Girbau, MD Phd, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00863213     History of Changes
Other Study ID Numbers: SARA-08, EudraCT: 2008-006095-30
Study First Received: March 16, 2009
Last Updated: April 25, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Catheter Ablation, Radiofrequency
Atrial fibrillation
Antiarrhythmic Drugs

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014