Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation (TOUCH AF)

Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:

1. guided by contact force sensing (CFS) OR
2. blinded to contact force sensing (CFS) - i.e. standard approach

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Vancouver Island Cardiac Arrhythmia Clinic
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Quebec City, Quebec, Canada, G1V 0A6
      • Laval University Cardiac and Pulmonary Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Age > 18 years.
• Patients undergoing first-time catheter ablation for AF.
• Persistent AF defined as episodes greater than 7 days duration.
• Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
• At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
• Willing and able to provide informed consent.

Exclusion Criteria

• Paroxysmal AF.
• AF secondary to a reversible cause.
• Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
• Patients who have previously undergone AF ablation.
• Patients with left atrial size >55 mm (echocardiography, parasternal long axis view).
• Patients who are or may potentially be pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Contact Force Sensing (CFS) Blinded; Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)	Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster
ACTIVE_COMPARATOR: Contact Force Sensing (CFS) Guided; Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)	Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cumulative radio frequency (RF) delivery time	Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AF or atrial arrhythmia >30 sec	Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation	12 months
Ability to achieve PV isolation with a single ring of lesions around each PV	Ability to achieve PV isolation with a single ring of lesions around each PV	6 hours
Ability to achieve linear ablation with complete conduction block on the first attempt	Ability to achieve linear ablation with complete conduction block on the first attempt	6 hours
Number & location of conduction gaps after initial circumferential ablation lines	Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure	6 hours
Number & location of conduction gaps after initial linear ablation	Number & location of conduction gaps after initial linear ablation during first ablation procedure	6 hours
Time required for successful PV isolation	Time required for successful PV isolation taking into consideration all ablation procedures	12 months
Time required for successful linear ablation	Time required for successful linear ablation taking into consideration all ablation procedures	12 months
Total fast anatomical mapping (FAM) time	Total FAM time taking into consideration all ablation procedures	12 months
FAM volume	FAM volume of CFS vs non-CFS guided maps	12 months
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis	Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis	90 days
Incidence of repeat ablation procedures		12 months
Incidence of conduction gaps around pulmonary veins	Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps	12 months
Freedom from atrial arrhythmia > 30 sec	Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure	12 months
Freedom from atrial arrhythmia > 30 sec after one or two procedures	Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures	12 months
Reduction in atrial arrhythmia burden by >90%		12 months

Collaborators and Investigators

• Sponsor: Southlake Regional Health Centre
• Collaborators: Applied Health Research Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): February 15, 2017
• Study Completion (ACTUAL): February 15, 2017

Study Registration Dates

• First Submitted: May 5, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (ESTIMATE): May 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 01 (Miami VAHS)