Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias

Study Overview
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Brief Summary
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The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a non-irrigated mode) in these procedures.

Detailed Description
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Rationale: Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk. Primary Objective: The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach. Secondary Objective: Secondary objectives of the study are the followings: to demonstrate that contact-force-sensing catheters are superior in terms of total procedure duration and fluoroscopy times in the case of AVNRT/WPW-AVRT ablation. to show that the use of contact-force sensing catheters is non-inferior to conventional catheters (without contact-force-sensing) in terms of acute/long-term procedural success and procedural safety (major/minor complication rate) of AVNRT/WPW-AVRT ablations. Study population: All patients above 18 years without structural heart disease being referred for electrophysiological study and potential treatment with radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) with manifest (WPW syndrome) or concealed accessory pathways. Intervention: One group undergoes manual ablation using standard non-irrigated ablation catheters and the other group undergoes manual ablation with an open-irrigated ablation catheter equipped with CF- sensing (and utilized in a non-irrigated mode during ablation) Main study parameters/endpoints: The main study endpoint is the difference in RF application number during the procedures of AVNRT/WPW-AVRT ablation; secondary endpoints are differences in RF application rate, acute success rate, long-term recurrence rate (1 year) major/minor complication rate, and total procedure/fluoroscopy time.

Official Title
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Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial

Conditions
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Tachycardia; Paroxysmal, Supraventricular, Tachycardia, Supraventricular

Intervention / Treatment
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* Procedure: Standard catheter ablation
* Procedure: Contact Force-sensing-based catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study Verbal consent to continue with ablation therapy Informed written consent to be included in the study Exclusion Criteria: evidence of structural heart disease and/or myocardial ischemia pregnancy (and lack of exclusion of potential pregnancy) age below 18 years

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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No

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 |
| --- | --- |
| Active Comparator: CONVENTIONAL group<br>Patients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter | Procedure: Standard catheter ablation<br>* Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing<br>|
| Experimental: CONTACT-FORCE group<br>Patients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter | Procedure: Contact Force-sensing-based catheter ablation<br>* Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of radiofrequency applications | The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT | From the beginning till the end of the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall duration of radiofrequency applications | total of time spend from the beginning till the end of the ablation procedure | From the beginning till the end of the ablation procedure | 
| Long-term procedural success | Free from recurrence of pre-excitation or the same clinical type of paroxysmal supraventricular tachycardia (AVNRT or AVRT) | At 12 months | 
| Acute procedural success/failure | non-inducibility of clinical arrhythmia verified at the end of the standard EP study | at the end of the ablation procedure | 
| Fluoroscopy time | total time for fluoroscopy time | From the beginning till the end of the ablation procedure | 
| Total duration of procedure | total time for duration of the procedure | From the beginning till the end of the ablation procedure | 
| (Serious) Adverse Events | all reported SAEs | Till 12 months | 
| Time to recurrence of AVNRT/WPW-AVRT | if recurrence of AVNRT/WPW-AVRT, time to recurrence | up till 12 months |