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Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Primary Purpose

Atrial Fibrillation, Catheter Ablation

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Additional Complex Fractionated Electrograms ablation

Standard atrial fibrillation ablation procedure

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Complex fractionated electrograms, CFAE

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Clinic Universitari de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ACVP plus roof line

Additional CFAEs ablation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Freedom from atrial arrhythmias without antiarrhythmic drugs

Secondary Outcome Measures

Freedom form atrial arrhythmias with or without antiarrhythmic drugs

Presence of any complications in the acute phase or during follow-up

Freedom from atypical atria flutter

Increase in radioscopy time and radiofrequency application time

Full Information

NCT ID

NCT00873067

First Posted

March 31, 2009

Last Updated

February 26, 2014

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacio Clinic Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT00873067

Brief Title

Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Official Title

Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacio Clinic Barcelona

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Catheter Ablation

Keywords

Atrial fibrillation, Complex fractionated electrograms, CFAE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACVP plus roof line

Arm Type

Active Comparator

Arm Description

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

Arm Title

Additional CFAEs ablation

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Additional Complex Fractionated Electrograms ablation

Other Intervention Name(s)

Complex atrial fractionated electrograms ablation

Intervention Description

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

Intervention Name(s)

Standard atrial fibrillation ablation procedure

Other Intervention Name(s)

ACVP ablation, Roof line

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom from atrial arrhythmias without antiarrhythmic drugs

Time Frame

1-year follow-up

Secondary Outcome Measure Information:

Title

Freedom form atrial arrhythmias with or without antiarrhythmic drugs

Time Frame

1-year follow-up

Title

Presence of any complications in the acute phase or during follow-up

Time Frame

1-year follow-up

Title

Freedom from atypical atria flutter

Time Frame

1-year follow-up

Title

Increase in radioscopy time and radiofrequency application time

Time Frame

1-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lluís Mont, MD

Organizational Affiliation

Hospital Clinic Universitary de Barcelona

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Elena Arbelo, MD, PhD

Organizational Affiliation

Hospital Clínic Universitari de Barcelona

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Clinic Universitari de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

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Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

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