Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873067
• Other study ID #: HCP/08/207-4495-CFAE
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2009
• Last updated: February 26, 2014
• Start date: January 2009
• Est. completion date: September 2013

Study information

• Verified date: September 2011
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic Universitari de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundacio Clinic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmias without antiarrhythmic drugs		1-year follow-up	No
Secondary	Freedom form atrial arrhythmias with or without antiarrhythmic drugs		1-year follow-up	No
Secondary	Presence of any complications in the acute phase or during follow-up		1-year follow-up	Yes
Secondary	Freedom from atypical atria flutter		1-year follow-up	No
Secondary	Increase in radioscopy time and radiofrequency application time		1-year follow-up	Yes