Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

NCT ID: NCT00873067

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation Catheter Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ACVP plus roof line

Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.

Group Type ACTIVE_COMPARATOR

Standard atrial fibrillation ablation procedure

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Additional Complex Fractionated Electrograms ablation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Complex atrial fractionated electrograms ablation ACVP ablation Roof line

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio Clinic Barcelona

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

Head of the Arrhythmia Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lluís Mont, MD

Role: STUDY_CHAIR

Hospital Clinic Universitary de Barcelona

Elena Arbelo, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clínic Universitari de Barcelona

Locations

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Hospital Clinic Universitari de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HCP/08/207-4495-CFAE

Identifier Type: -

Identifier Source: org_study_id

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