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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrial Flutter, Radiofrequency Catheter Ablation

Intervention / Treatment
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* Device: Contact force guided RFA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operator guided by contact force<br>Operator has full access to contact force parameters including force time integral (FTI). | Device: Contact force guided RFA<br>* Contact force guided RFA during Atrial Flutter ablation procedure.<br>|
| No Intervention: Operator blinded to contact force<br>Operator is blinded to contact force with ablation guided by standard markers of effective ablation. | |

What is the study measuring?
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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 |