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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Atrial fibrillation ablation
Antiarrhythmic drug
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter Ablation, Radiofrequency, Atrial fibrillation, Antiarrhythmic Drugs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Cruces
  • Hospital Clinic Universitari
  • Hospital de Sant Pau
  • Clínica Puerta de Hierro
  • Hospital 12 de Octubre
  • Hospital Clínico San Carlos
  • Hospital Gregorio Marañon
  • Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atrial Fibrillation Ablation

Drug therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2009
Last Updated
April 25, 2013
Sponsor
Hospital Clinic of Barcelona
Collaborators
Medtronic, Fundacio Clinic Barcelona, Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00863213
Brief Title
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Acronym
SARA
Official Title
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Medtronic, Fundacio Clinic Barcelona, Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter Ablation, Radiofrequency, Atrial fibrillation, Antiarrhythmic Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrial Fibrillation Ablation
Arm Type
Experimental
Arm Title
Drug therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Intervention Description
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 Outcome Measure Information:
Title
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Time Frame
1-year follow-up
Secondary Outcome Measure Information:
Title
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
Time Frame
1-year follow-up
Title
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
Time Frame
1-year follow-up
Title
Decrease in atrial fibrillation/atrial flutter related hospital admissions
Time Frame
1-year follow-up
Title
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
Time Frame
1-year follow-up
Title
Change in need of cardioversions
Time Frame
From 3rd to 12th months
Title
Need of atrio-ventricular node ablation
Time Frame
1-year follow-up
Title
Need of crossover to the other arm of the study (only when primary end point has been reached)
Time Frame
1-year follow-up
Title
Need of a new intervention or ablation during blanking period
Time Frame
Until 3rd month
Title
Detection of asymptomatic episodes by Reveal XT
Time Frame
1-year follow-up
Title
Presence of any complications in the acute phase or during follow-up
Time Frame
1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluís Mont, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angel Arenal, MD
Organizational Affiliation
Hospital Gregorio Marañon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julian Villacastin, MD
Organizational Affiliation
Hospital San Carlos, Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Josep Brugada, prof Md. PHD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Cruces
City
Bilbao
State/Province
Bizkaia
Country
Spain
Facility Name
Hospital Clinic Universitari
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Facility Name
Clínica Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24135832
Citation
Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457. Epub 2013 Oct 17.
Results Reference
derived

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Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

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