Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
- Conditions
- Atrial FlutterRadiofrequency Catheter Ablation
- Interventions
- Device: Contact force guided RFA
- Registration Number
- NCT02825498
- Lead Sponsor
- Victoria Cardiac Arrhythmia Trials
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Operator guided by contact force Contact force guided RFA Operator has full access to contact force parameters including force time integral (FTI).
- Primary Outcome Measures
Name Time Method Efficacy of RFA Determined during RFA procedure Total RFA time required to achieve bidirectional block
- Secondary Outcome Measures
Name Time Method Recurrence of atrial flutter Assessed at 12 weeks and 12 months post CTI RFA procedure Documented recurrence of atrial flutter
Average total CF achieved Determined during RFA procedure Average total CF per ablation per segment (third) of the CTI.
Average axial CF achieved Determined during RFA procedure Average axial CF per ablation per segment (third) of the CTI.
Average FTI achieved Determined during RFA procedure Average FTI per ablation per segment (third) of the CTI.
Average lateral CF achieved Determined during RFA procedure Average lateral CF per ablation per segment (third) of the CTI.
Average lesion size index (LSI) achieved Determined during RFA procedure Average lesion size index (LSI) per ablation per segment (third) of the CTI.
Procedural complication rate Determined during RFA procedure and at 12 weeks post RFA procedure Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.
Average total CF of segment of acute and delayed reconnection Determined during index and repeat RFA procedure Average total CF per ablation in segment (third) of acute or delayed reconnection.
Average lateral CF of segment of acute and delayed reconnection Determined during index and repeat RFA procedure Average lateral CF per ablation in segment (third) of acute or delayed reconnection.
Average axial CF of segment of acute and delayed reconnection Determined during index and repeat RFA procedure Average axial CF per ablation in segment (third) of acute or delayed reconnection.
Average FTI of segment of acute and delayed reconnection Determined during index and repeat RFA procedure Average FTI per ablation in segment (third) of acute or delayed reconnection.
Procedural efficacy of RFA Determined during RFA procedure Total procedural time required to achieve bidirectional block
Average lesion size index (LSI) of segment of acute and delayed reconnection Determined during index and repeat RFA procedure Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection.
Trial Locations
- Locations (1)
Victoria Cardiac Arrhythmia Trials
🇨🇦Victoria, British Columbia, Canada