Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

This study has been completed.
Sponsor:
Collaborator:
Fundacio Clinic
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00873067
First received: March 31, 2009
Last updated: February 26, 2014
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Catheter Ablation
Procedure: Additional Complex Fractionated Electrograms ablation
Procedure: Standard atrial fibrillation ablation procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Freedom from atrial arrhythmias without antiarrhythmic drugs [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom form atrial arrhythmias with or without antiarrhythmic drugs [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Presence of any complications in the acute phase or during follow-up [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]
  • Freedom from atypical atria flutter [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • Increase in radioscopy time and radiofrequency application time [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 142
Study Start Date: January 2009
Study Completion Date: September 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Complex atrial fractionated electrograms ablation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873067

Locations
Spain
Hospital Clinic Universitari de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fundacio Clinic
Investigators
Study Chair: Lluís Mont, MD Hospital Clinic Universitary de Barcelona
Study Director: Elena Arbelo, MD, PhD Hospital Clínic Universitari de Barcelona
  More Information

No publications provided

Responsible Party: Josep Lluis Mont Girbau, Head of the Arrhythmia Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00873067     History of Changes
Other Study ID Numbers: HCP/08/207-4495-CFAE
Study First Received: March 31, 2009
Last Updated: February 26, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Atrial fibrillation
Complex fractionated electrograms
CFAE

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014