Back to resultsRandomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Primary Purpose
Atrial Flutter, Radiofrequency Catheter Ablation
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Contact force guided RFA
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility 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)
Sites / Locations
- Victoria Cardiac Arrhythmia Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Operator guided by contact force
Operator blinded to contact force
Arm Description
Operator has full access to contact force parameters including force time integral (FTI).
Operator is blinded to contact force with ablation guided by standard markers of effective ablation.
Outcomes
Primary Outcome Measures
Efficacy of RFA
Total RFA time required to achieve bidirectional block
Secondary Outcome Measures
Recurrence of atrial flutter
Documented recurrence of atrial flutter
Average total CF achieved
Average total CF per ablation per segment (third) of the CTI.
Average axial CF achieved
Average axial CF per ablation per segment (third) of the CTI.
Average FTI achieved
Average FTI per ablation per segment (third) of the CTI.
Average lateral CF achieved
Average lateral CF per ablation per segment (third) of the CTI.
Average lesion size index (LSI) achieved
Average lesion size index (LSI) per ablation per segment (third) of the CTI.
Procedural complication rate
Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.
Average total CF of segment of acute and delayed reconnection
Average total CF per ablation in segment (third) of acute or delayed reconnection.
Average lateral CF of segment of acute and delayed reconnection
Average lateral CF per ablation in segment (third) of acute or delayed reconnection.
Average axial CF of segment of acute and delayed reconnection
Average axial CF per ablation in segment (third) of acute or delayed reconnection.
Average FTI of segment of acute and delayed reconnection
Average FTI per ablation in segment (third) of acute or delayed reconnection.
Average lesion size index (LSI) of segment of acute and delayed reconnection
Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection.
Procedural efficacy of RFA
Total procedural time required to achieve bidirectional block
Full Information
NCT ID
NCT02825498
First Posted
July 4, 2016
Last Updated
May 19, 2020
Sponsor
Victoria Cardiac Arrhythmia Trials
1. Study Identification
Unique Protocol Identification Number
NCT02825498
Brief Title
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Official Title
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Victoria Cardiac Arrhythmia Trials
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter, Radiofrequency Catheter Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operator guided by contact force
Arm Type
Experimental
Arm Description
Operator has full access to contact force parameters including force time integral (FTI).
Arm Title
Operator blinded to contact force
Arm Type
No Intervention
Arm Description
Operator is blinded to contact force with ablation guided by standard markers of effective ablation.
Intervention Type
Device
Intervention Name(s)
Contact force guided RFA
Intervention Description
Contact force guided RFA during Atrial Flutter ablation procedure.
Primary Outcome Measure Information:
Title
Efficacy of RFA
Description
Total RFA time required to achieve bidirectional block
Time Frame
Determined during RFA procedure
Secondary Outcome Measure Information:
Title
Recurrence of atrial flutter
Description
Documented recurrence of atrial flutter
Time Frame
Assessed at 12 weeks and 12 months post CTI RFA procedure
Title
Average total CF achieved
Description
Average total CF per ablation per segment (third) of the CTI.
Time Frame
Determined during RFA procedure
Title
Average axial CF achieved
Description
Average axial CF per ablation per segment (third) of the CTI.
Time Frame
Determined during RFA procedure
Title
Average FTI achieved
Description
Average FTI per ablation per segment (third) of the CTI.
Time Frame
Determined during RFA procedure
Title
Average lateral CF achieved
Description
Average lateral CF per ablation per segment (third) of the CTI.
Time Frame
Determined during RFA procedure
Title
Average lesion size index (LSI) achieved
Description
Average lesion size index (LSI) per ablation per segment (third) of the CTI.
Time Frame
Determined during RFA procedure
Title
Procedural complication rate
Description
Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.
Time Frame
Determined during RFA procedure and at 12 weeks post RFA procedure
Title
Average total CF of segment of acute and delayed reconnection
Description
Average total CF per ablation in segment (third) of acute or delayed reconnection.
Time Frame
Determined during index and repeat RFA procedure
Title
Average lateral CF of segment of acute and delayed reconnection
Description
Average lateral CF per ablation in segment (third) of acute or delayed reconnection.
Time Frame
Determined during index and repeat RFA procedure
Title
Average axial CF of segment of acute and delayed reconnection
Description
Average axial CF per ablation in segment (third) of acute or delayed reconnection.
Time Frame
Determined during index and repeat RFA procedure
Title
Average FTI of segment of acute and delayed reconnection
Description
Average FTI per ablation in segment (third) of acute or delayed reconnection.
Time Frame
Determined during index and repeat RFA procedure
Title
Average lesion size index (LSI) of segment of acute and delayed reconnection
Description
Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection.
Time Frame
Determined during index and repeat RFA procedure
Title
Procedural efficacy of RFA
Description
Total procedural time required to achieve bidirectional block
Time Frame
Determined during RFA procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Novak, MD
Organizational Affiliation
Victoria Cardiac Arrhythmia Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
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