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

June 22, 2009
June 5, 2014
August 2009
November 2011   (final data collection date for primary outcome measure)
  • 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.
  • Incidence of AF termination/regularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • RF delivery time per procedure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Change in AF cycle length from baseline to the end of ablation procedure for each target [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and distribution of RF lesions points created [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926783 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 3, 6, 9, and 12 month follow-up visits [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events during the study [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Procedure duration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrial Fibrillation
Procedure: CFAE ablation
CFAE ablation (targeted vs. generalized)
Other Names:
  • CFAE ablation (targeted vs. generalized)
  • NaviStar ThermoCool Catheter
  • CARTO mapping system
  • Active Comparator: (1) targeted CFAE ablation
    Intervention: Procedure: CFAE ablation
  • Active Comparator: (2) generalized CFAE ablation
    Intervention: Procedure: CFAE ablation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
September 2013
November 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00926783
SELECT-AF
No
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Study Director: Chris Hendricks Biosense Webster, Inc.
Biosense Webster, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP