Persistent Atrial FibrillationCOAST-AFNCT02184013
Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study
A study testing Catheter ablation in people with Persistent Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 14 Sep 2015to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study
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.
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Catheter ablation
- Keywords
- Atrial fibrillation, Catheter ablation, Delayed gadolinium enhanced MRI, C-metahydroxyepherdrine (HED) PET scan, ECGI mapping, Atrial Fibrosis, Atrial sympathetic denervation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation (AF) Termination
AF termination resulting in restoration of sinus rhythm during ablation.
Measured: During catheter ablation
Secondary outcomes (3)
Radio frequency (RF) ablation time
Measured: During catheter ablation
Procedure Duration
Total procedure duration
Measured: During catheter ablation
Freedom from AF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study start14 Sep 2015
- Primary completion23 Aug 2018
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo B Nery, MD, Principal investigator, Ottawa Heart Institute Research CorporationRobert deKemp, PhD, Principal investigator, Ottawa Heart Institute Research CorporationElena Pena, MD, Principal investigator, The Ottawa HospitalDavid H Birnie, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184013
- Sponsor's protocol ID
- 20140623
- Acronym
- COAST-AF
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2014
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes