Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation - Full Text View

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

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

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: 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

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 23, 2012