Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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