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Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study (COAST-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02184013
Recruitment Status : Active, not recruiting
First Posted : July 8, 2014
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date November 13, 2020
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Atrial Fibrillation (AF) Termination [ Time Frame: During catheter ablation ]
AF termination resulting in restoration of sinus rhythm during ablation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Radio frequency (RF) ablation time [ Time Frame: During catheter ablation ]
  • Procedure Duration [ Time Frame: During catheter ablation ]
    Total procedure duration
  • Freedom from AF [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study
Official Title  ICMJE Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study
Brief Summary

This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial fibrillation and in guiding an innovative AF catheter ablation strategy.

It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis with enhanced imaging and performing an individualized innovative AF catheter ablation will result in higher procedural success rates.

Detailed Description

Pulmonary vein isolation catheter ablation for the treatment of persistent AF (PeAF)or longstanding persistent AF is associated with success rates of 40-50% at one year. Experimental models have shown that AF results in progressive structural changes due to electrical atrial remodeling, where AF burden correlates with atrial fibrosis. The optimal ablation strategy for patients with PeAF is not yet known. There is limited understanding of the critical mechanisms responsible for maintenance of AF in these patients.

In this study ECG body mapping (ECGI) will be used to look for distinct electrical rotors in the atria. Delayed gadolinium enhanced magnetic resonance imaging (DE-MRI) will be used to assess the extent of left atrial fibrosis. In addition to PVI catheter ablation procedure, an ablation strategy guided by the results of the ECGI mapping and DE-MRI will be performed.A C-metahydroxyepherdrine (HED) PET scan will also be done pre-ablation to evaluate left atrial sympathetic denervation and any relationship to the initiation and/or maintenance of AF.

Subjects will be seen at 3 and 6 months after ablation, with 12 lead ECG and 2-week loop monitoring done at each visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE Procedure: Catheter ablation
Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 11, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
30
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years and ≤ 80 years;
  • Symptomatic persistent AF AND clinically indicated for AF catheter ablation
  • At least one episode of AF lasting more than 7 days, documented on 12-lead ECG, Holter monitor, 2-week loop monitor or trans-telephonic monitor (TTM) within 12 months of enrollment in the study
  • Able to provide informed consent.

Exclusion Criteria:

  • History of previous catheter or surgical ablation for AF
  • Presence of intracardiac thrombus
  • contraindication to systemic oral anticoagulation therapy
  • Subjects with reversible causes of AF
  • Antero-posterior left atrial dimension > 60 mm on echocardiography
  • Severe valvular disease (mitral/aortic stenosis or regurgitation);
  • Subjects that are pregnant or breastfeeding;
  • Chronic kidney disease and creatinine clearance <50ml/min.
  • Contraindication to MRI Imaging (e.g. permanent pacemaker, metallic implants, etc)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02184013
Other Study ID Numbers  ICMJE 20140623
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pablo B Nery, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Robert deKemp, PhD Ottawa Heart Institute Research Corporation
Principal Investigator: Elena Pena, MD The Ottawa Hospital
Principal Investigator: David H Birnie, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date November 2020

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