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

June 22, 2009
February 5, 2013
August 2009
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
  • 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 ]
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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.
February 2013

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