Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study

Persistent Atrial Fibrillation Clinical Trial

— COAST-AF  

Official title:

Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02184013
• Other study ID #: 20140623
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation (AF) Termination	AF termination resulting in restoration of sinus rhythm during ablation.	During catheter ablation
Secondary	Radio frequency (RF) ablation time		During catheter ablation
Secondary	Procedure Duration	Total procedure duration	During catheter ablation
Secondary	Freedom from AF		6 months