FAST Mapping During Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FAST mapping and ablation
PVI
Sponsored by

About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- All patients must be over the age 18 and have a clinical indication for their first catheter ablation of AF because of symptomatic AF.
- This will include patients with either high burden paroxysmal (>4 self-terminating episodes of AF within the last 6 months with two episodes lasting at least 6 hours within the last year) or persistent AF (lasting ≥7 days, but which can still be converted to sinus rhythm).
Exclusion Criteria:
The major exclusion criteria will include:
- long-standing persistent AF (ie. AF which cannot be converted to sinus rhythm, or where multiple attempts at restoring sinus rhythm have failed)
- rheumatic valvular disease
- hypertrophic cardiomyopathy
- uncorrected cardiac shunts (eg. secundum ASD)
- severe mitral regurgitation or mechanical mitral valve
- left atrial size >55 mm (echo derived parasternal long axis view).
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FAST ablation + PVI
PVI
Arm Description
FAST mapping and ablation will be performed in addition to PVI
Pulnonary vein isolation will be performed
Outcomes
Primary Outcome Measures
Time to first symptomatic atrial fibrillation recurrence postablation
Secondary Outcome Measures
Full Information
NCT ID
NCT02271152
First Posted
October 18, 2014
Last Updated
March 4, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02271152
Brief Title
FAST Mapping During Atrial Fibrillation
Official Title
Focal Electrical Source and Trigger Mapping During Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence of 8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure and mortality. AF catheter ablation is an important treatment strategy for patients suffering from AF, but the success rate remains low after conventional pulmonary vein isolation (PVI). The mechanism perpetuating AF is poorly understood. Focal electrical sources and triggers (FAST) may sustain AF in some patients, which makes them a potential therapeutic target for ablation. However, finding FAST is very challenging due to complex nature of AF electrical signals. In this study, the investigators will attempt to localize focal electrical sources and triggers (FAST mapping) in patients undergoing AF ablation using custom software that evaluates periodicity and waveform morphology. Patients will be randomized to one of two AF ablation strategies, namely FAST mapping/ablation + PVI vs. PVI alone. The investigators will determine which strategy leads to better clinical outcome postablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FAST ablation + PVI
Arm Type
Experimental
Arm Description
FAST mapping and ablation will be performed in addition to PVI
Arm Title
PVI
Arm Type
Active Comparator
Arm Description
Pulnonary vein isolation will be performed
Intervention Type
Procedure
Intervention Name(s)
FAST mapping and ablation
Intervention Type
Procedure
Intervention Name(s)
PVI
Primary Outcome Measure Information:
Title
Time to first symptomatic atrial fibrillation recurrence postablation
Time Frame
3 months postablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must be over the age 18 and have a clinical indication for their first catheter ablation of AF because of symptomatic AF.
This will include patients with either high burden paroxysmal (>4 self-terminating episodes of AF within the last 6 months with two episodes lasting at least 6 hours within the last year) or persistent AF (lasting ≥7 days, but which can still be converted to sinus rhythm).
Exclusion Criteria:
The major exclusion criteria will include:
long-standing persistent AF (ie. AF which cannot be converted to sinus rhythm, or where multiple attempts at restoring sinus rhythm have failed)
rheumatic valvular disease
hypertrophic cardiomyopathy
uncorrected cardiac shunts (eg. secundum ASD)
severe mitral regurgitation or mechanical mitral valve
left atrial size >55 mm (echo derived parasternal long axis view).
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
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FAST Mapping During Atrial Fibrillation
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