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Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation (SELECT-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
CFAE ablation
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring paroxysmal, persistent, targeted, generalized, CFAE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Loyola University Medical Center
  • Johns Hopkins University
  • Royal Adelaide Hospital
  • Hamilton Health Sciences Centre
  • Southlake Regional Health Center
  • Montreal Heart Institute
  • Hopital Laval - Institut universitaire de cardiologie et de pneumonologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

(1) targeted CFAE ablation

(2) generalized CFAE ablation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
June 22, 2009
Last Updated
June 5, 2014
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00926783
Brief Title
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Acronym
SELECT-AF
Official Title
Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
paroxysmal, persistent, targeted, generalized, CFAE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(1) targeted CFAE ablation
Arm Type
Active Comparator
Arm Title
(2) generalized CFAE ablation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
CFAE ablation
Other Intervention Name(s)
CFAE ablation (targeted vs. generalized), NaviStar ThermoCool Catheter, CARTO mapping system
Intervention Description
CFAE ablation (targeted vs. generalized)
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.
Description
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.
Time Frame
From day 91 to day 365 post first ablation procedure
Title
Total Radio-frequency (RF) Delivery Time During CFAE
Description
Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.
Time Frame
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary Outcome Measure Information:
Title
Duration of Ablation Procedure
Description
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.
Time Frame
Duration of ablation procedure (up to about 5 hours)
Title
Fluoroscopy Time
Description
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.
Time Frame
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Title
Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target
Description
Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
Time Frame
Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
Title
Incidence of Atrial Fibrillation (AF) Termination/Regularization
Description
Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.
Time Frame
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Hendricks
Organizational Affiliation
Biosense Webster, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Laval - Institut universitaire de cardiologie et de pneumonologie
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24425420
Citation
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.
Results Reference
derived

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

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