Atrial Fibrillation Force Contact Ablation Study (CAFCAS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Peter Leong-Sit, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01693107
First received: September 17, 2012
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Phase
Paroxysmal Atrial Fibrillation
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Canadian Atrial Fibrillation Force Contact Ablation Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Procedural Time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ] [ Designated as safety issue: No ]
    Length of time between first ablation and last ablation


Secondary Outcome Measures:
  • Lesion Recovery [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Localization of recovered gaps

  • Ablation Time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ] [ Designated as safety issue: No ]
    Total time of ablation used during procedure

  • Number of ablation lesions [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ] [ Designated as safety issue: No ]
    Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Operator Blinded to Contact Force
Physicians performing the ablation will be blinded to the contact force data

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693107

Contacts
Contact: Cathy Bentley, RN 519-685-8500 ext 35835 cbentl@uwo.ca
Contact: Lynn Nyman, RN 519-685-8500 ext 35994 lnyman@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Peter Leong-Sit, MD Western University
  More Information

No publications provided

Responsible Party: Peter Leong-Sit, Assistant Professor, Division of Cardiology, Western University, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01693107     History of Changes
Other Study ID Numbers: Version 20120423
Study First Received: September 17, 2012
Last Updated: September 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Atrial Fibrillation
Catheter Ablation
Electrophysiology
Cardiac Arrhythmias

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014