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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088126

Enrollment

Registered

2010-03-17

Start date

2010-01-31

Completion date

2017-03-02

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Brief 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.

Interventions

PROCEDUREradiofrequency catheter ablation

radiofrequency catheter ablation, NavX system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
freedom from AF/AT more than 3 months after first ablation	12 months

Secondary

Measure	Time frame
acute intra-procedure termination of AF	12 months
organization of AF/conversion to AT during the ablation	12 months
freedom from AF/AT within 3 months following first ablation	3 months
ablation time	12 months
procedure-related complication	12 months
procedure time	12 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026