FAST Mapping During Atrial Fibrillation

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02271152

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: FAST mapping and ablation Procedure: PVI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Focal Electrical Source and Trigger Mapping During Atrial Fibrillation

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FAST ablation + PVI FAST mapping and ablation will be performed in addition to PVI	Procedure: FAST mapping and ablation Procedure: PVI
Active Comparator: PVI Pulnonary vein isolation will be performed	Procedure: PVI

Arm

Intervention/Treatment

Experimental: FAST ablation + PVI

FAST mapping and ablation will be performed in addition to PVI

Procedure: FAST mapping and ablation

Procedure: PVI

Active Comparator: PVI

Pulnonary vein isolation will be performed

Procedure: PVI

Outcome Measures

Primary Outcome Measures

Time to first symptomatic atrial fibrillation recurrence postablation [3 months postablation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vijay Chauhan, Cardiologist, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02271152

Other Study ID Numbers:

2013-121

First Posted:

Oct 22, 2014

Last Update Posted:

Mar 6, 2019

Last Verified:

Mar 1, 2019

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Mar 6, 2019