Clinical trial NCT02184013: Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study
Official title: Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Delayed gadolinium enhanced MRI
C-metahydroxyepherdrine (HED) PET scan
ECGI mapping
Atrial Fibrosis
Atrial sympathetic denervation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Atrial Fibrillation (AF) Termination
timeFrame: During catheter ablation
Secondary outcomes:
measure: Radio frequency (RF) ablation time
timeFrame: During catheter ablation
measure: Procedure Duration
timeFrame: During catheter ablation
measure: Freedom from AF
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Pablo B Nery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Robert deKemp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Elena Pena, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: David H Birnie, MD
role: PRINCIPAL_INVESTIGATOR
References: