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

This study is currently recruiting participants.
Verified June 2013 by Southlake Regional Health Centre
Sponsor:
Collaborator:
Applied Health Research Centre (AHRC)
Information provided by (Responsible Party):
Atul Verma, Southlake Regional Health Centre
ClinicalTrials.gov Identifier:
NCT01851525
First received: May 5, 2013
Last updated: June 20, 2013
Last verified: June 2013

May 5, 2013
June 20, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01851525 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Persistent Atrial Fibrillation
Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster
  • 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)
    Intervention: 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)
    Intervention: Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact: Atul Verma, MD 905-895-4521 atul.verma@utoronto.ca
Canada
 
NCT01851525
01
No
Atul Verma, Southlake Regional Health Centre
Southlake Regional Health Centre
Applied Health Research Centre (AHRC)
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
Southlake Regional Health Centre
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP