Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study (COAST-AF)
Primary Purpose
Persistent Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial fibrillation, Catheter ablation, Delayed gadolinium enhanced MRI, C-metahydroxyepherdrine (HED) PET scan, ECGI mapping, Atrial Fibrosis, Atrial sympathetic denervation
Eligibility Criteria
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)
Sites / Locations
- University of Ottawa Heart Institute
Outcomes
Primary Outcome Measures
Atrial Fibrillation (AF) Termination
AF termination resulting in restoration of sinus rhythm during ablation.
Secondary Outcome Measures
Radio frequency (RF) ablation time
Procedure Duration
Total procedure duration
Freedom from AF
Full Information
NCT ID
NCT02184013
First Posted
July 2, 2014
Last Updated
March 3, 2023
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02184013
Brief Title
Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study
Acronym
COAST-AF
Official Title
Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial fibrillation, Catheter ablation, Delayed gadolinium enhanced MRI, C-metahydroxyepherdrine (HED) PET scan, ECGI mapping, Atrial Fibrosis, Atrial sympathetic denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
Primary Outcome Measure Information:
Title
Atrial Fibrillation (AF) Termination
Description
AF termination resulting in restoration of sinus rhythm during ablation.
Time Frame
During catheter ablation
Secondary Outcome Measure Information:
Title
Radio frequency (RF) ablation time
Time Frame
During catheter ablation
Title
Procedure Duration
Description
Total procedure duration
Time Frame
During catheter ablation
Title
Freedom from AF
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo B Nery, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert deKemp, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena Pena, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David H Birnie, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study
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