NCT02184013

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2015Dec 2027

First Submitted

Initial submission to the registry

July 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 14, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

May 6, 2026

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

July 2, 2014

Last Update Submit

April 29, 2026

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillationCatheter ablationDelayed gadolinium enhanced MRIC-metahydroxyepherdrine (HED) PET scanECGI mappingAtrial FibrosisAtrial sympathetic denervation

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation (AF) Termination

    AF termination resulting in restoration of sinus rhythm during ablation.

    During catheter ablation

Secondary Outcomes (3)

  • Radio frequency (RF) ablation time

    During catheter ablation

  • Procedure Duration

    During catheter ablation

  • Freedom from AF

    6 months

Interventions

Catheter ablationPROCEDURE

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 8, 2014

Study Start

September 14, 2015

Primary Completion

August 23, 2018

Study Completion (Estimated)

December 31, 2027

Last Updated

May 6, 2026

Record last verified: 2025-08

Locations

CA(1)