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

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ClinicalTrials.gov Identifier: NCT01851525
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Atul Verma, Southlake Regional Health Centre

Brief Summary:

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 or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Study Start Date : June 2013
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Total cumulative radio frequency (RF) delivery time [ Time Frame: 12 months ]
    Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)


Secondary Outcome Measures :
  1. Freedom from AF or atrial arrhythmia >30 sec [ Time Frame: 12 months ]
    Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation

  2. Ability to achieve PV isolation with a single ring of lesions around each PV [ Time Frame: 6 hours ]
    Ability to achieve PV isolation with a single ring of lesions around each PV

  3. Ability to achieve linear ablation with complete conduction block on the first attempt [ Time Frame: 6 hours ]
    Ability to achieve linear ablation with complete conduction block on the first attempt

  4. Number & location of conduction gaps after initial circumferential ablation lines [ Time Frame: 6 hours ]
    Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure

  5. Number & location of conduction gaps after initial linear ablation [ Time Frame: 6 hours ]
    Number & location of conduction gaps after initial linear ablation during first ablation procedure

  6. Time required for successful PV isolation [ Time Frame: 12 months ]
    Time required for successful PV isolation taking into consideration all ablation procedures

  7. Time required for successful linear ablation [ Time Frame: 12 months ]
    Time required for successful linear ablation taking into consideration all ablation procedures

  8. Total fast anatomical mapping (FAM) time [ Time Frame: 12 months ]
    Total FAM time taking into consideration all ablation procedures

  9. FAM volume [ Time Frame: 12 months ]
    FAM volume of CFS vs non-CFS guided maps

  10. 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 ]
    Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis

  11. Incidence of repeat ablation procedures [ Time Frame: 12 months ]
  12. Incidence of conduction gaps around pulmonary veins [ Time Frame: 12 months ]
    Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps

  13. Freedom from atrial arrhythmia > 30 sec [ Time Frame: 12 months ]
    Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure

  14. Freedom from atrial arrhythmia > 30 sec after one or two procedures [ Time Frame: 12 months ]
    Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures

  15. Reduction in atrial arrhythmia burden by >90% [ Time Frame: 12 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Atul Verma, Principal Investigator, Southlake Regional Health Centre
ClinicalTrials.gov Identifier: NCT01851525     History of Changes
Other Study ID Numbers: 01
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Atul Verma, Southlake Regional Health Centre:
Atrial fibrillation
Ablation

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