Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:

Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01088126
• Other study ID #: AN09239
• Status: Withdrawn
• Phase: N/A
• First received: March 1, 2010
• Last updated: March 19, 2018
• Start date: January 2010
• Est. completion date: March 2, 2017

Study information

• Verified date: January 2010
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2, 2017
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients age 18 or greater

• persistent atrial fibrillation

• candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication

• at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial

• continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation

• patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

• paroxysmal or permanent atrial fibrillation

• patients with AF felt to be secondary to an obvious reversible cause

• inadequate anticoagulation as defined in the inclusion criteria

• left atrial thrombus on TEE prior to procedure

• contraindications to systemic anticoagulation with heparin or coumadin

• previously undergone atrial fibrillation ablation

• patients who are or may potentially be pregnant

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• radiofrequency catheter ablation
radiofrequency catheter ablation, NavX system

Locations

Country	Name	City	State
Korea, Republic of	Korea University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	freedom from AF/AT more than 3 months after first ablation		12 months
Secondary	freedom from AF/AT within 3 months following first ablation		3 months
Secondary	acute intra-procedure termination of AF		12 months
Secondary	organization of AF/conversion to AT during the ablation		12 months
Secondary	procedure time		12 months
Secondary	ablation time		12 months
Secondary	procedure-related complication		12 months