FAST Mapping During Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Focal Electrical Source and Trigger Mapping During Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271152
• Other study ID #: 2013-121
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2019

Study information

• Verified date: March 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• FAST mapping and ablation

• PVI

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first symptomatic atrial fibrillation recurrence postablation		3 months postablation