FAST Mapping During Atrial Fibrillation

University Health Network, Toronto

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: PVI; Procedure: FAST mapping and ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02271152

2013-121

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

FAST ablation + PVI

Experimental group

Description:

FAST mapping and ablation will be performed in addition to PVI

Treatment:

Procedure: PVI

Procedure: FAST mapping and ablation

PVI

Active Comparator group

Description:

Pulnonary vein isolation will be performed

Treatment:

Procedure: PVI