Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
This study is currently recruiting participants.
Verified September 2011 by Hospital Clinic of Barcelona
Sponsor:
Hospital Clinic of Barcelona
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: September 22, 2011
Last verified: September 2011
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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 ]
| Estimated Enrollment: | 142 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (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:
|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873067
Contacts
| Contact: Lluís Mont, MD, PhD | +34932275551 | lmont@clinic.ub.es |
| Contact: Elena Arbelo, MD, PhD | +34932275551 | earbelo@clinic.ub.es |
Locations
| Spain | |
| Hospital Clinic Universitari de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Lluís Mont, MD, PhD +34932275551 lmont@clinic.ub.es | |
| Contact: Elena Arbelo, MD, PhD +34932275551 earbelo@clinic.ub.es | |
| Principal Investigator: Lluís Mont, MD | |
| Principal Investigator: Elena Arbelo, MD, PhD | |
| Sub-Investigator: Antonio Berruezo, MD, PhD | |
| Sub-Investigator: José M Tolosana, MD | |
| Sub-Investigator: Esther Guiú, B Eng | |
| Sub-Investigator: David Andreu, B Eng | |
| Sub-Investigator: Roger Borras, B Sc | |
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: | September 22, 2011 |
| 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 Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013