Atrial Fibrillation Force Contact Ablation Study (CAFCAS)

The Canadian Atrial Fibrillation Force Contact Ablation Study

This study will be divided into two phases. The purpose of the Phase I registry is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.

In Phase II of the study, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the THERMOCOOL® SMARTTOUCH™ catheter.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population above the age of 65 years. The use of percutaneous catheter ablation for symptomatic management has increased over the last decade. It is well established that AF ablation is superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success rates with a single procedure for paroxysmal AF is approximately 80% with the majority of recurrence due to recovery of lesions or "gaps" found at repeat procedures.

In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo ablation using a newly Health Canada approved catheter with SmartTouch technology that enables the measurement of catheter tip contact force and direction inside the heart. The purpose of Phase I of the study is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.

The secondary objective will be to assess whether lesion recovery, as assessed in redo procedures, corresponds to contact force measurements. It is hypothesized that gaps found on repeat procedures will correspond to ablation lesions associated with a lower contact force.

In Phase II, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the SmartTouch catheter. It is hypothesized that the open use of contact force data will decrease the procedural time and number of lesions to achieve bidirectional pulmonary vein isolation.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal atrial fibrillation who have failed antiarrhythmic medications and scheduled for a pulmonary vein isolation procedure.

Description

Inclusion Criteria:

• Patients aged 18 years or greater.
• Patients undergoing first-time pulmonary vein catheter ablation for AF.
• Patients with paroxysmal AF. Paroxysmal AF will be defined as symptomatic episodes of AF lasting less than 7 days or treated with cardioversion(s) within 48 hours of onset.
• At least one episode of AF must have been documented on telemetry, ambulatory monitor, or 12-lead ECG.
• Patients must be able and willing to provide written informed consent to participate in the clinical study.

Exclusion Criteria:

• Patients with a history of any previous ablation for atrial fibrillation.
• Patients with a previous atriotomy scar, ie. Mitral or tricuspid valve replacement or repair, ASD surgery, cardiac transplant.
• Patients with an intracardiac thrombus
• Patients who are or may potentially be pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Operator Blinded to Contact Force; Physicians performing the ablation will be blinded to the contact force data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Time	Length of time between first ablation and last ablation	participants will be followed for the duration of hospital stay, an expected average of 36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Recovery	Localization of recovered gaps	up to 1 year
Ablation Time	Total time of ablation used during procedure	participants will be followed for the duration of hospital stay, an expected average of 36 hours
Number of ablation lesions	Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins	participants will be followed for the duration of hospital stay, an expected average of 36 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Peter Leong-Sit, MD, Western University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (ESTIMATE): September 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation; Electrophysiology; Cardiac Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Version 20120423