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Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH)

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ClinicalTrials.gov Identifier: NCT04078685
Recruitment Status : Recruiting
First Posted : September 5, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tamás Géczy, Erasmus Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tachycardia; Paroxysmal, Supraventricular Tachycardia, Supraventricular Procedure: Standard catheter ablation Procedure: Contact Force-sensing-based catheter ablation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall duration of radiofrequency applications [ Time Frame: From the beginning till the end of the ablation procedure ]
  2. 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)

  3. 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

  4. Fluoroscopy time [ Time Frame: From the beginning till the end of the ablation procedure ]
  5. Total duration of procedure [ Time Frame: From the beginning till the end of the ablation procedure ]
  6. (Serious) Adverse Events [ Time Frame: Till 12 months ]
  7. Time to recurrence of AVNRT/WPW-AVRT [ Time Frame: up till 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Tamas Geczy, MD, PhD +31643247432 t.geczy@erasmusmc.nl
Contact: Tamas Szili-Torok, MD, PhD +31633330605

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Tamas Szili-Torok, MD, PhD    +31633330605    t.szilitorok@erasmusmc.nl   
Contact: Tamas Geczy, MD, PhD    +31643247432    t.geczy@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center

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Responsible Party: Tamás Géczy, Cardiologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04078685     History of Changes
Other Study ID Numbers: NL62017.078.17
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Tachycardia, Paroxysmal
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes