Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH)
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|ClinicalTrials.gov Identifier: NCT04078685|
Recruitment Status : Unknown
Verified September 2020 by Tamás Géczy, Erasmus Medical Center.
Recruitment status was: Active, not recruiting
First Posted : September 6, 2019
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia; Paroxysmal, Supraventricular Tachycardia, Supraventricular||Procedure: Standard catheter ablation Procedure: Contact Force-sensing-based catheter ablation||Not Applicable|
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.
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 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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial|
|Actual Study Start Date :||June 12, 2018|
|Actual Primary Completion Date :||March 9, 2020|
|Estimated Study Completion Date :||March 20, 2021|
Active Comparator: CONVENTIONAL group
Patients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter
Procedure: Standard catheter ablation
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
Experimental: CONTACT-FORCE group
Patients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter
Procedure: Contact Force-sensing-based catheter ablation
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter
- Number of radiofrequency applications [ Time Frame: From the beginning till the end of the ablation procedure ]The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT
- Overall duration of radiofrequency applications [ Time Frame: From the beginning till the end of the ablation procedure ]total of time spend from the beginning till the end of the ablation procedure
- Long-term procedural success [ Time Frame: At 12 months ]Free from recurrence of pre-excitation or the same clinical type of paroxysmal supraventricular tachycardia (AVNRT or AVRT)
- Acute procedural success/failure [ Time Frame: at the end of the ablation procedure ]non-inducibility of clinical arrhythmia verified at the end of the standard EP study
- Fluoroscopy time [ Time Frame: From the beginning till the end of the ablation procedure ]total time for fluoroscopy time
- Total duration of procedure [ Time Frame: From the beginning till the end of the ablation procedure ]total time for duration of the procedure
- (Serious) Adverse Events [ Time Frame: Till 12 months ]all reported SAEs
- Time to recurrence of AVNRT/WPW-AVRT [ Time Frame: up till 12 months ]if recurrence of AVNRT/WPW-AVRT, time to recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078685
|Rotterdam, Netherlands, 3015 GD|
|Principal Investigator:||Tamas Szili-Torok, MD, PhD||Erasmus Medical Center|