Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

February 26, 2014 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Universitari de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACVP plus roof line
Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.
Procedure: Standard atrial fibrillation ablation 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
Active Comparator: Additional CFAEs ablation
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.
Procedure: Additional Complex Fractionated Electrograms ablation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial arrhythmias without antiarrhythmic drugs
Time Frame: 1-year follow-up
1-year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of any complications in the acute phase or during follow-up
Time Frame: 1-year follow-up
1-year follow-up
Freedom form atrial arrhythmias with or without antiarrhythmic drugs
Time Frame: 1-year follow-up
1-year follow-up
Freedom from atypical atria flutter
Time Frame: 1-year follow-up
1-year follow-up
Increase in radioscopy time and radiofrequency application time
Time Frame: 1-year follow-up
1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacio Clinic Barcelona

Investigators

  • Study Chair: Lluís Mont, MD, Hospital Clinic Universitary de Barcelona
  • Study Director: Elena Arbelo, MD, PhD, Hospital Clinic Universitari de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCP/08/207-4495-CFAE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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