Phase 4 N=83 Randomized Single-blind Treatment

Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00926783 ↗

Enrolled (actual)

Serious AEs

31.3%

Results posted

Jun 2014

Primary outcome: Primary: Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. — 10; 18; 29; 20 participants — p=0.048

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: CFAE ablation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biosense Webster, Inc.
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.	10; 18; 29; 20	0.048 sig
PRIMARY Total Radio-frequency (RF) Delivery Time During CFAE	23.2; 37.8	0.002 sig
SECONDARY Duration of Ablation Procedure	220.6; 226.1; 42.7; 45.4; 35.7; 27.4	—
SECONDARY Fluoroscopy Time	57.4; 60.1; 9.7; 11.8; 15.5; 13.8	—
SECONDARY Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target	23.3; 25.4	—
SECONDARY Incidence of Atrial Fibrillation (AF) Termination/Regularization	11; 14	—

Summary

This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation. Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to be blinded to the randomization.

Eligibility Criteria

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

Age ≥ 18 years old
First-time ablation procedure for AF
Symptomatic AF which has been refractory to at least one antiarrhythmic medication (AAD). "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the above
One of the following must apply:
AF must either be PERSISTENT AF (non-US sites only) or HIGH BURDEN PAROXYSMAL AF - High burden paroxysmal AF is defined as episodes that terminate within 30 days and meet any ONE of the following criteria:
More than 1 episode of AF per month in the preceding 6 months with at least 1 episode lasting >24 hours by symptoms,
LA size of >/= 48 mm in the PLAX (parasternal long axis) view on echocardiography
LA volume >/= 100 cc
Total AF history >/= 10 years
At least one episode of AF must have been documented by ECG, Holter, TTM, or telemetry strip within 24 months of inclusion in the study.
Patients must be able and willing to provide written informed consent to participate in the study.
Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions apply:

Patients with long-standing persistent AF >1 year for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
Patients with AF felt to be secondary to an obvious reversible cause.
Patients with contraindications to systemic anticoagulation with heparin or Coumadin.
Patients who have previously undergone atrial fibrillation ablation.
Patients who are pregnant (by history of menses or pregnancy test if history is considered unreliable.
Left atrial size ≥55 mm (PLAX view on echocardiography).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00926783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.