Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00926783
First received: June 22, 2009
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Procedure: CFAE ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. [ Time Frame: From day 91 to day 365 post first ablation procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Duration of ablation procedure (up to about 5 hours) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ] [ Designated as safety issue: Yes ]
    Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.


Enrollment: 86
Study Start Date: August 2009
Study Completion Date: September 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: (1) targeted CFAE ablation Procedure: CFAE ablation
CFAE ablation (targeted vs. generalized)
Other Names:
  • CFAE ablation (targeted vs. generalized)
  • NaviStar ThermoCool Catheter
  • CARTO mapping system
Active Comparator: (2) generalized CFAE ablation Procedure: CFAE ablation
CFAE ablation (targeted vs. generalized)
Other Names:
  • CFAE ablation (targeted vs. generalized)
  • NaviStar ThermoCool Catheter
  • CARTO mapping system

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926783

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Southlake Regional Health Center
Newmarket, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Hopital Laval - Institut universitaire de cardiologie et de pneumonologie
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Study Director: Chris Hendricks Biosense Webster, Inc.
  More Information

No publications provided by Biosense Webster, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00926783     History of Changes
Other Study ID Numbers: SELECT-AF
Study First Received: June 22, 2009
Results First Received: March 24, 2014
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee

Keywords provided by Biosense Webster, Inc.:
paroxysmal
persistent
targeted
generalized
CFAE

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014