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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Southlake Regional Health Centre.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Atul Verma, Southlake Regional Health Centre
ClinicalTrials.gov Identifier:
NCT01851525
First received: May 5, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention
Persistent Atrial Fibrillation
Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Resource links provided by NLM:


Further study details as provided by Southlake Regional Health Centre:

Primary Outcome Measures:
  • Total cumulative radio frequency (RF) delivery time [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)


Secondary Outcome Measures:
  • Freedom from AF or atrial arrhythmia >30 sec [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation

  • Ability to achieve PV isolation with a single ring of lesions around each PV [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Ability to achieve PV isolation with a single ring of lesions around each PV

  • Ability to achieve linear ablation with complete conduction block on the first attempt [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Ability to achieve linear ablation with complete conduction block on the first attempt

  • Number & location of conduction gaps after initial circumferential ablation lines [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure

  • Number & location of conduction gaps after initial linear ablation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Number & location of conduction gaps after initial linear ablation during first ablation procedure

  • Time required for successful PV isolation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time required for successful PV isolation taking into consideration all ablation procedures

  • Time required for successful linear ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time required for successful linear ablation taking into consideration all ablation procedures

  • Total fast anatomical mapping (FAM) time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total FAM time taking into consideration all ablation procedures

  • FAM volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    FAM volume of CFS vs non-CFS guided maps

  • Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis

  • Incidence of repeat ablation procedures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of conduction gaps around pulmonary veins [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps

  • Freedom from atrial arrhythmia > 30 sec [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure

  • Freedom from atrial arrhythmia > 30 sec after one or two procedures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures

  • Reduction in atrial arrhythmia burden by >90% [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01851525

Locations
Canada, British Columbia
Vancouver Island Cardiac Arrhythmia Clinic
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Laval University Cardiac and Pulmonary Institute
Quebec City, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Southlake Regional Health Centre
Applied Health Research Centre
Investigators
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
  More Information

Responsible Party: Atul Verma, Principal Investigator, Southlake Regional Health Centre
ClinicalTrials.gov Identifier: NCT01851525     History of Changes
Other Study ID Numbers: 01 
Study First Received: May 5, 2013
Last Updated: April 22, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Southlake Regional Health Centre:
Atrial fibrillation
Ablation

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

ClinicalTrials.gov processed this record on January 18, 2017