Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Atrial fibrillation ablation (Procedure); Antiarrhythmic drug (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s):
Lluís Mont, MD, Study Chair, Affiliation: Hospital Clinic de Barcelona
Angel Arenal, MD, Study Director, Affiliation: Hospital Gregorio Marañon
Julian Villacastin, MD, Study Director, Affiliation: Hospital Clínico San Carlos
Overall contact:
Lluis Mont, MD, Phone: +34932275551, Email: lmont@clinic.ub.es
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.
Clinical Details
Official title: Study of Ablation vs antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Freedom from recurrent atrial fibrillation or atrial flutter, lasting more than 24 hours or requiring cardioversion.
Secondary outcome: Freedom form atrial fibrillation or atrial flutter (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 SF-36 questionnaire 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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Lluis Mont, MD, Phone: +34932275551, Email: lmont@clinic.ub.es
Hospital Clinic Universitari, Barcelona 08036, Spain; Recruiting
Lluís Mont, MD, Principal Investigator
Hospital de Sant Pau, Barcelona, Spain; Recruiting
Xavier Viñolas, MD, Principal Investigator
Hospital Gregorio Marañon, Madrid, Spain; Recruiting
Angel Arenal, MD, Principal Investigator
Hospital Clínico San Carlos, Madrid, Spain; Recruiting
Julián Villacastin, MD, Principal Investigator
Hospital Ramón y Cajal, Madrid, Spain; Recruiting
Antonio Hernandez Madrid, MD, Principal Investigator
Clínica Puerta de Hierro, Madrid, Spain; Recruiting
Ingacio Fernández-Lozano, MD, Principal Investigator
Hospital 12 de Octubre, Madrid, Spain; Recruiting
Fernando Arribas, MD, Principal Investigator
Hospital de Cruces, Bilbao, Bizkaia, Spain; Recruiting
Andres Bodegas, MD, Principal Investigator
Additional Information
Starting date: March 2009
Ending date: March 2012
Last updated: June 29, 2009
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