Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Catheter Ablation

Treatments: Procedure: Additional Complex Fractionated Electrograms ablation; Procedure: Standard atrial fibrillation ablation procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00873067

HCP/08/207-4495-CFAE

Details and patient eligibility

About

The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.

Enrollment: 142 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
• Presence of atrial fibrillation at the beginning of the procedure

Exclusion criteria

• Hypo or hyperthyroidism
• Persistent long-lasting or non-defined duration atrial fibrillation
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

ACVP plus roof line

Active Comparator group

Description:

Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.

Treatment:

Procedure: Standard atrial fibrillation ablation procedure

Additional CFAEs ablation

Active Comparator group

Description:

Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.

Treatment:

Procedure: Additional Complex Fractionated Electrograms ablation