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Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (COAST-AF RCT)

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ClinicalTrials.gov Identifier: NCT03347227
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).

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

Detailed Description:

The optimal CA strategy for persistent AF remains unknown. Current data highlight the need for a better understanding of the substrate and mechanisms of arrhythmia maintenance in this population. Atrial scar-based catheter ablation has recently emerged as a promising strategy for ablation of AF. However, the available data has limitations that preclude definitive conclusions regarding the utility of this strategy (no data from multicenter, randomized studies available). Further research is needed to assess the role of scar-based ablation for persistent AF.

The Investigators hypothesize that catheter ablation of persistent AF (PeAF) tailored to abolish abnormal atrial substrate identified by intracardiac atrial scar mapping in addition to pulmonary vein isolation (PVI) will result in higher procedural success rates when compared to PVI alone.

The study will recruit 502 patients with PeAF (251 per treatment arm) who are candidates for CA ablation of AF according to the treating physician (and in agreement with current practice guidelines). Subjects will be recruited over a 42 month period. The total duration of the study is 60 months.

Prior to undergoing catheter ablation subjects will be seen by the investigator/ research assistant and the following data will be collected:

i. Age and sex ii. Structural heart disease if present iii. CHADS2VASc score iv. DR-FLASH score v. NYHA class vi. Current medications vii. Duration of uninterrupted AF viii. Height and weight ix. Echocardiogram and other cardiac imaging results (within previous 12 months, including assessment of left ventricular ejection fraction, left atrial volume and valve function) x. ECG, Holter or loop monitor recording (within past 36 months) documenting AF.

Subjects will be randomly assigned in a 1:1 ratio to undergo wide area circumferential ablation for pulmonary vein isolation (PVI- control arm) or wide area circumferential ablation PVI and scar ablation (experimental arm). Randomization will be stratified by centre and by sex. Subjects will be randomized prior to the procedure.

Enrolled subjects will have a clinical follow-up visit at 3, 6, 12 and 18 months after the ablation procedure. A 14-day continuous ambulatory ECG monitor will be completed at each visit. The results of monitoring will be interpreted at a centralized core lab, and the results will be adjudicated by an arrhythmia specialist blinded to treatment group. A total of three questionnaires will be administered throughout the study, each at a specific time point. The Quality of Life (EQ-5D), CCS-Severity of AF scale, and Atrial Fibrillation Effect on Quality of life (AFEQT) will be completed at baseline, and at the 12-month and 18 month visit.

Concomitant medical therapy will be selected according to the treating physician. All subjects will be maintained on systemic oral anticoagulation for at least 2 months following catheter ablation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, parallel arm randomized clinical trial
Masking: Single (Participant)
Masking Description: Single-blinded
Primary Purpose: Treatment
Official Title: Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (Coast-AF) Randomized Clinical Trial
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pulmonary Vein Isolation
Wide area circumferential catheter ablation for pulmonary vein isolation
Procedure: Catheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Other Name: Atrial Fibrillation Ablation

Experimental: Pulmonary Vein Isolation and scar ablation
Wide area circumferential catheter ablation for pulmonary vein isolation and scar ablation
Procedure: Catheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Other Name: Atrial Fibrillation Ablation




Primary Outcome Measures :
  1. Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation [ Time Frame: day 91 post ablation to 18 months ]
    Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds


Secondary Outcome Measures :
  1. AF burden [ Time Frame: At 12 months and 18 monts ]
    Documented amount of AF

  2. Need for repeat ablation procedure for AF, AFl or AT [ Time Frame: Up to 18 months ]
    Documented by ECG, holter or ECG loop recorder

  3. Need for emergency room visits or hospitalization [ Time Frame: Up to 18 months ]
    Hospital admission for > 24 hours and emergency room admission

  4. Incidence of any ECG documented AF with 90 days of ablation [ Time Frame: up to 90 days ]
    Symptomatic or asymptomatic AF

  5. Time to first recurrence at 18 months according to sex and atrial scar extent [ Time Frame: 18 months ]
    Recurrence of AF, AFl or AT

  6. Composite safety outcome [ Time Frame: Up to 18 months ]
    Procedure related complications at any time (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death

  7. Total ablation delivery time [ Time Frame: Day of ablation procedure ]
    RF ablation time

  8. Total procedure duration [ Time Frame: Day of ablation procedure ]
    Start of ablation to end of ablation

  9. Quality of life analyses [ Time Frame: 18 months ]
    Using EQ-5D general quality of life score, and AF severity scale (symptoms and functionality)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years ;
  2. Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF
  3. At least one episode of AF that is sustained beyond 3 months in duration ; documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;
  4. Modified DR-FLASH score >=4

4. Subjects must be able to provide informed consent.

Exclusion Criteria:

  1. History of previous catheter ablation for AF or left atrial flutter;
  2. History of previous surgical ablation for AF;
  3. Known intracardiac thrombus;
  4. Contraindication to systemic oral anticoagulation therapy;
  5. Reversible causes of AF;
  6. Hypertrophic cardiomyopathy;
  7. Severe valvular disease (mitral/aortic stenosis or regurgitation);
  8. Subjects that are pregnant or breastfeeding;
  9. Comorbid condition with life expectancy < 1 year

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): NCT03347227


Contacts
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Contact: Pablo Nery, MD 613-696-7272 pnery@ottawaheart.ca
Contact: Karen MacDonald 613-696-7000 ext 17077 kmacdonald@ottawaheart.ca

Locations
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Canada, Alberta
Libin Cardiovascular Institute Recruiting
Calgary, Alberta, Canada
Contact: George Veenhuyzen, MD         
Principal Investigator: George Veenhuyzen, MD         
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Jason Andrade, MD         
Principal Investigator: Jason Andrade, MD         
Canada, Nova Scotia
QEII Health Sciences Centre, Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: John Sapp, MD         
Principal Investigator: John Sapp, MD         
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Jorge Wong, MD         
Principal Investigator: Jorge Wong, MD         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: Allan Skanes, MD         
Principal Investigator: Allan Skanes, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Atul Verma, MD         
Principal Investigator: Atul Verma, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Pablo Nery, MD    613-696-7272    pnery@ottawaheart.ca   
Sub-Investigator: David Birnie, MD         
Principal Investigator: Pablo Nery, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Paul Angaran, MD         
Principal Investigator: Paul Angaran, MD         
Rouge Valley Regional Heart Centre Recruiting
Toronto, Ontario, Canada
Contact: Derek Yung, MD         
Principal Investigator: Derek Yung, Md         
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM) Not yet recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Jean-Marc Raymond, MD         
Principal Investigator: Jean-Marc Raymond, MD         
Sacre-Coeur Hospital Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Mario Sturmer, MD         
Principal Investigator: Mario Sturmer, MD         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Vidal Essebag, MD         
Principal Investigator: Jacqueline Joza, MD         
Montreal Heart Institute Not yet recruiting
Montreal, Quebec, Canada
Contact: Laurent Macle, MD         
Principal Investigator: Laurent Macle, MD         
Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ) Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Contact: Isabelle Nault, MD         
Principal Investigator: Isabelle Nault, MD         
CIUSSS de L'Estrie-CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Charles Dussault, MD         
Principal Investigator: Charles Dussault, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Canada
Investigators
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Principal Investigator: Pablo Nery, MD Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03347227    
Other Study ID Numbers: 20170
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
AF ablation
Pulmonary vein isolation
Atrial scar ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes