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

Atrial Fibrillation Clinical Trial

— SELECT-AF  

Official title:

Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926783
• Other study ID #: SELECT-AF
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2009
• Last updated: June 5, 2014
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review CommitteeAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• CFAE ablation
CFAE ablation (targeted vs. generalized)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional Health Center	Newmarket	Ontario
Canada	Hopital Laval - Institut universitaire de cardiologie et de pneumonologie	Quebec City	Quebec
United States	Johns Hopkins University	Baltimore	Maryland
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.	Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.	From day 91 to day 365 post first ablation procedure	No
Primary	Total Radio-frequency (RF) Delivery Time During CFAE	Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.	Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)	Yes
Secondary	Duration of Ablation Procedure	Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.	Duration of ablation procedure (up to about 5 hours)	No
Secondary	Fluoroscopy Time	Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.; Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis.	Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)	No
Secondary	Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target	Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target	Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)	No
Secondary	Incidence of Atrial Fibrillation (AF) Termination/Regularization	Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.	Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)	Yes