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Completed

NCT Number: NCT00873067

Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic Universitari de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional Complex Fractionated Electrograms ablation

Procedure

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.

Other names: Complex atrial fractionated electrograms ablation

Standard atrial fibrillation ablation procedure

Procedure

Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.

Other names: ACVP ablation, Roof line

Primary outcomes

  1. Freedom from atrial arrhythmias without antiarrhythmic drugs

    Time frame: 1-year follow-up

Secondary outcomes

  1. Freedom form atrial arrhythmias with or without antiarrhythmic drugs

    Time frame: 1-year follow-up

  2. Presence of any complications in the acute phase or during follow-up

    Time frame: 1-year follow-up

  3. Freedom from atypical atria flutter

    Time frame: 1-year follow-up

  4. Increase in radioscopy time and radiofrequency application time

    Time frame: 1-year follow-up

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundacio Clinic Barcelona

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Apr 1, 2009
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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