FAST Mapping During Atrial Fibrillation

NCT02271152 | Completed

• 1 other identifier: 2013-121
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to first symptomatic atrial fibrillation recurrence postablation

  3 months postablation

Study Arms (2)

FAST ablation + PVI

EXPERIMENTAL

FAST mapping and ablation will be performed in addition to PVI

Procedure: FAST mapping and ablation; Procedure: PVI

PVI

ACTIVE COMPARATOR

Pulnonary vein isolation will be performed

Procedure: PVI

Interventions

FAST mapping and ablation PROCEDURE

FAST ablation + PVI

PVI PROCEDURE

FAST ablation + PVI; PVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: October 18, 2014
• First Posted: October 22, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

CA (1)