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Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter

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ClinicalTrials.gov Identifier: NCT02825498
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Victoria Cardiac Arrhythmia Trials

Study Description
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Brief Summary:
Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.

Condition or disease Intervention/treatment Phase
Atrial Flutter Radiofrequency Catheter Ablation Device: Contact force guided RFA Not Applicable

Detailed Description:
Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Actual Study Start Date : May 18, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Operator guided by contact force
Operator has full access to contact force parameters including force time integral (FTI).
 Device: Contact force guided RFA
Contact force guided RFA during Atrial Flutter ablation procedure.
No Intervention: Operator blinded to contact force
Operator is blinded to contact force with ablation guided by standard markers of effective ablation.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of RFA [ Time Frame: Determined during RFA procedure ]
    Total RFA time required to achieve bidirectional block


Secondary Outcome Measures :
  1. Recurrence of atrial flutter [ Time Frame: Assessed at 12 weeks and 12 months post CTI RFA procedure ]
    Documented recurrence of atrial flutter

  2. Average total CF achieved [ Time Frame: Determined during RFA procedure ]
    Average total CF per ablation per segment (third) of the CTI.

  3. Average axial CF achieved [ Time Frame: Determined during RFA procedure ]
    Average axial CF per ablation per segment (third) of the CTI.

  4. Average FTI achieved [ Time Frame: Determined during RFA procedure ]
    Average FTI per ablation per segment (third) of the CTI.

  5. Average lateral CF achieved [ Time Frame: Determined during RFA procedure ]
    Average lateral CF per ablation per segment (third) of the CTI.

  6. Average lesion size index (LSI) achieved [ Time Frame: Determined during RFA procedure ]
    Average lesion size index (LSI) per ablation per segment (third) of the CTI.

  7. Procedural complication rate [ Time Frame: Determined during RFA procedure and at 12 weeks post RFA procedure ]
    Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.

  8. Average total CF of segment of acute and delayed reconnection [ Time Frame: Determined during index and repeat RFA procedure ]
    Average total CF per ablation in segment (third) of acute or delayed reconnection.

  9. Average lateral CF of segment of acute and delayed reconnection [ Time Frame: Determined during index and repeat RFA procedure ]
    Average lateral CF per ablation in segment (third) of acute or delayed reconnection.

  10. Average axial CF of segment of acute and delayed reconnection [ Time Frame: Determined during index and repeat RFA procedure ]
    Average axial CF per ablation in segment (third) of acute or delayed reconnection.

  11. Average FTI of segment of acute and delayed reconnection [ Time Frame: Determined during index and repeat RFA procedure ]
    Average FTI per ablation in segment (third) of acute or delayed reconnection.

  12. Average lesion size index (LSI) of segment of acute and delayed reconnection [ Time Frame: Determined during index and repeat RFA procedure ]
    Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection.

  13. Procedural efficacy of RFA [ Time Frame: Determined during RFA procedure ]
    Total procedural time required to achieve bidirectional block


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
  • Able and willing to give informed consent.

Exclusion Criteria:

  • Previous CTI ablation
  • Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
Contacts and Locations
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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): NCT02825498


Locations
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Canada, British Columbia
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
Sponsors and Collaborators
Victoria Cardiac Arrhythmia Trials
Investigators
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Principal Investigator: Paul Novak, MD Victoria Cardiac Arrhythmia Trials
More Information
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Responsible Party: Victoria Cardiac Arrhythmia Trials
ClinicalTrials.gov Identifier: NCT02825498     History of Changes
Other Study ID Numbers: C2016-012
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified IPD may be shared with other researchers upon study completion. Data may be obtained by contacting Victoria Cardiac Arrhythmia Trials Inc. at 250-595-0400.
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes