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

NCT ID: NCT00926783

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-09-30

Brief 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.

Detailed Description

The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(1) targeted CFAE ablation

Group Type: ACTIVE_COMPARATOR

CFAE ablation

Intervention Type: PROCEDURE

CFAE ablation (targeted vs. generalized)

(2) generalized CFAE ablation

Group Type: ACTIVE_COMPARATOR

CFAE ablation

Intervention Type: PROCEDURE

CFAE ablation (targeted vs. generalized)

Interventions

CFAE ablation

CFAE ablation (targeted vs. generalized)

Intervention Type: PROCEDURE

Other Intervention Names

CFAE ablation (targeted vs. generalized); NaviStar ThermoCool Catheter; CARTO mapping system

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Hendricks

Role: STUDY_DIRECTOR

Biosense Webster, Inc.

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Southlake Regional Health Center

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Hopital Laval - Institut universitaire de cardiologie et de pneumonologie

Québec, Quebec, Canada

Countries

United States; Australia; Canada

References

Verma A, Sanders P, Champagne J, Macle L, Nair GM, Calkins H, Wilber DJ. Selective complex fractionated atrial electrograms targeting for atrial fibrillation study (SELECT AF): a multicenter, randomized trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):55-62. doi: 10.1161/CIRCEP.113.000890. Epub 2014 Jan 14.

Reference Type: DERIVED

PMID: 24425420 (View on PubMed)

Other Identifiers

SELECT-AF

Identifier Type: -

Identifier Source: org_study_id