Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SARA  

Official title:

Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863213
• Other study ID #: SARA-08
• Secondary ID: EudraCT: 2008-00
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2009
• Last updated: April 25, 2013
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic Universitari	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital de Cruces	Bilbao	Bizkaia
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

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Biosense Webster, Inc., Fundacio Clinic, Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.		1-year follow-up	No
Secondary	Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.		1-year follow-up	No
Secondary	Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.		1-year follow-up	No
Secondary	Decrease in atrial fibrillation/atrial flutter related hospital admissions		1-year follow-up	No
Secondary	Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.		1-year follow-up	No
Secondary	Change in need of cardioversions		From 3rd to 12th months	No
Secondary	Need of atrio-ventricular node ablation		1-year follow-up	No
Secondary	Need of crossover to the other arm of the study (only when primary end point has been reached)		1-year follow-up	No
Secondary	Need of a new intervention or ablation during blanking period		Until 3rd month	No
Secondary	Detection of asymptomatic episodes by Reveal XT		1-year follow-up	No
Secondary	Presence of any complications in the acute phase or during follow-up		1-year follow-up	Yes