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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00926783
First received: June 22, 2009
Last updated: February 5, 2013
Last verified: February 2013
  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:
  • Freedom from atrial arrhythmia at one year [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Total RF delivery time per procedure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from AF in each arm without AADs at 6, 9, and 12 months (excluding atrial tachycardia, flutter) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Freedom from AF in each arm with AADs at 6, 9, and 12 months (excluding atrial tachycardia, flutter) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Freedom from atrial arrhythmia at 6 and 9 month follow-up visits without AADs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Freedom from atrial arrhythmia at 6 and 9 month follow up visits with AADs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Procedure duration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of AF termination/regularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and distribution of RF lesion points created [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events occurring within 7 days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Freedom from recurrence of AF at 12 months follow up visit following repeat ablation procedures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: August 2009
Estimated 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
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

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00926783     History of Changes
Other Study ID Numbers: SELECT-AF
Study First Received: June 22, 2009
Last Updated: February 5, 2013
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014