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OpenTrials
Completed

NCT Number: NCT01851525

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

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Island Cardiac Arrhythmia Clinic, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ThermoCoolSmartTouch ablation catheter, Biosense Webster

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Southlake Health

Other

Collaborators

  • Applied Health Research Centre

Registry information

Acronym: TOUCH AF

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 10, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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