NCT02184013

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Catheter ablation	Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).

Timeline

• Start date: 2015-09-14
• Primary completion: 2018-08-23
• Completion: 2026-01-31
• First posted: 2014-07-08
• Last updated: 2025-08-15

Locations

1 site across 1 country: Canada