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

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ThermoCoolSmartTouch ablation catheter, Biosense Webster
Sponsored by
Southlake Regional Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vancouver Island Cardiac Arrhythmia Clinic
  • Southlake Regional Health Centre
  • Montreal Heart Institute
  • Laval University Cardiac and Pulmonary Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Contact Force Sensing (CFS) Blinded

Contact Force Sensing (CFS) Guided

Arm Description

Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)

Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)

Outcomes

Primary Outcome Measures

Total cumulative radio frequency (RF) delivery time
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
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
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
Ability to achieve linear ablation with complete conduction block on the first attempt
Number & location of conduction gaps after initial circumferential ablation lines
Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure
Number & location of conduction gaps after initial linear ablation
Number & location of conduction gaps after initial linear ablation during first ablation procedure
Time required for successful PV isolation
Time required for successful PV isolation taking into consideration all ablation procedures
Time required for successful linear ablation
Time required for successful linear ablation taking into consideration all ablation procedures
Total fast anatomical mapping (FAM) time
Total FAM time taking into consideration all ablation procedures
FAM volume
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
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
Incidence of conduction gaps around pulmonary veins
Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps
Freedom from atrial arrhythmia > 30 sec
Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure
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
Reduction in atrial arrhythmia burden by >90%

Full Information

First Posted
May 5, 2013
Last Updated
April 24, 2017
Sponsor
Southlake Regional Health Centre
Collaborators
Applied Health Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01851525
Brief Title
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Acronym
TOUCH AF
Official Title
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southlake Regional Health Centre
Collaborators
Applied Health Research Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contact Force Sensing (CFS) Blinded
Arm Type
Active Comparator
Arm Description
Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)
Arm Title
Contact Force Sensing (CFS) Guided
Arm Type
Active Comparator
Arm Description
Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)
Intervention Type
Device
Intervention Name(s)
ThermoCoolSmartTouch ablation catheter, Biosense Webster
Primary Outcome Measure Information:
Title
Total cumulative radio frequency (RF) delivery time
Description
Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom from AF or atrial arrhythmia >30 sec
Description
Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation
Time Frame
12 months
Title
Ability to achieve PV isolation with a single ring of lesions around each PV
Description
Ability to achieve PV isolation with a single ring of lesions around each PV
Time Frame
6 hours
Title
Ability to achieve linear ablation with complete conduction block on the first attempt
Description
Ability to achieve linear ablation with complete conduction block on the first attempt
Time Frame
6 hours
Title
Number & location of conduction gaps after initial circumferential ablation lines
Description
Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure
Time Frame
6 hours
Title
Number & location of conduction gaps after initial linear ablation
Description
Number & location of conduction gaps after initial linear ablation during first ablation procedure
Time Frame
6 hours
Title
Time required for successful PV isolation
Description
Time required for successful PV isolation taking into consideration all ablation procedures
Time Frame
12 months
Title
Time required for successful linear ablation
Description
Time required for successful linear ablation taking into consideration all ablation procedures
Time Frame
12 months
Title
Total fast anatomical mapping (FAM) time
Description
Total FAM time taking into consideration all ablation procedures
Time Frame
12 months
Title
FAM volume
Description
FAM volume of CFS vs non-CFS guided maps
Time Frame
12 months
Title
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
Description
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
Title
Incidence of repeat ablation procedures
Time Frame
12 months
Title
Incidence of conduction gaps around pulmonary veins
Description
Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps
Time Frame
12 months
Title
Freedom from atrial arrhythmia > 30 sec
Description
Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure
Time Frame
12 months
Title
Freedom from atrial arrhythmia > 30 sec after one or two procedures
Description
Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures
Time Frame
12 months
Title
Reduction in atrial arrhythmia burden by >90%
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
Organizational Affiliation
Southlake Regional Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Island Cardiac Arrhythmia Clinic
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Laval University Cardiac and Pulmonary Institute
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

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