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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Flutter; Radiofrequency Catheter Ablation
• Intervention / Treatment: Device: Contact force guided RFA

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada
      • Victoria Cardiac Arrhythmia Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of RFA	Total RFA time required to achieve bidirectional block	Determined during RFA procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial flutter	Documented recurrence of atrial flutter	Assessed at 12 weeks and 12 months post CTI RFA procedure
Average total CF achieved	Average total CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Average axial CF achieved	Average axial CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Average FTI achieved	Average FTI per ablation per segment (third) of the CTI.	Determined during RFA procedure
Average lateral CF achieved	Average lateral CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Average lesion size index (LSI) achieved	Average lesion size index (LSI) per ablation per segment (third) of the CTI.	Determined during RFA procedure
Procedural complication rate	Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.	Determined during RFA procedure and at 12 weeks post RFA procedure
Average total CF of segment of acute and delayed reconnection	Average total CF per ablation in segment (third) of acute or delayed reconnection.	Determined during index and repeat RFA procedure
Average lateral CF of segment of acute and delayed reconnection	Average lateral CF per ablation in segment (third) of acute or delayed reconnection.	Determined during index and repeat RFA procedure
Average axial CF of segment of acute and delayed reconnection	Average axial CF per ablation in segment (third) of acute or delayed reconnection.	Determined during index and repeat RFA procedure
Average FTI of segment of acute and delayed reconnection	Average FTI per ablation in segment (third) of acute or delayed reconnection.	Determined during index and repeat RFA procedure
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.	Determined during index and repeat RFA procedure
Procedural efficacy of RFA	Total procedural time required to achieve bidirectional block	Determined during RFA procedure

Collaborators and Investigators

• Sponsor: Victoria Cardiac Arrhythmia Trials
• Investigators: Principal Investigator: Paul Novak, MD, Victoria Cardiac Arrhythmia Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: C2016-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.