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 : Active, not recruiting
First Posted : July 8, 2014
Last Update Posted : November 13, 2020
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|
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)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||December 2020|
- Procedure: Catheter ablation
Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
- Atrial Fibrillation (AF) Termination [ Time Frame: During catheter ablation ]AF termination resulting in restoration of sinus rhythm during ablation.
- 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 ]
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
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|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|