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

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ClinicalTrials.gov Identifier: NCT02184013
Recruitment Status : Recruiting
First Posted : July 8, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Catheter ablation Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study
Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Catheter ablation
    Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).


Primary Outcome Measures :
  1. Atrial Fibrillation (AF) Termination [ Time Frame: During catheter ablation ]
    AF termination resulting in restoration of sinus rhythm during ablation.


Secondary Outcome Measures :
  1. Radio frequency (RF) ablation time [ Time Frame: During catheter ablation ]
  2. Procedure Duration [ Time Frame: During catheter ablation ]
    Total procedure duration

  3. Freedom from AF [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184013


Contacts
Contact: Karen MacDonald, RN 6132-696-7000 ext 17077 kmacdonald@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Pablo B Nery, MD    613-696-7272    PNery@ottawaheart.ca   
Principal Investigator: Pablo B Nery, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02184013     History of Changes
Other Study ID Numbers: 20140623
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
Atrial fibrillation
Catheter ablation
Delayed gadolinium enhanced MRI
C-metahydroxyepherdrine (HED) PET scan
ECGI mapping
Atrial Fibrosis
Atrial sympathetic denervation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes