FAST Mapping During Atrial Fibrillation

NCT ID: NCT02271152

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-02-28

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FAST ablation + PVI

FAST mapping and ablation will be performed in addition to PVI

Group Type: EXPERIMENTAL

FAST mapping and ablation

Intervention Type: PROCEDURE

PVI

Intervention Type: PROCEDURE

PVI

Pulnonary vein isolation will be performed

Group Type: ACTIVE_COMPARATOR

PVI

Intervention Type: PROCEDURE

Interventions

FAST mapping and ablation

Intervention Type: PROCEDURE

PVI

Intervention Type: PROCEDURE

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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Vijay Chauhan

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2013-121

Identifier Type: -

Identifier Source: org_study_id