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

September 1, 2020 updated by: Tamás Géczy, Erasmus Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the beginning till the end of the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
At 12 months
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
at the end of the ablation procedure
Fluoroscopy time
Time Frame: From the beginning till the end of the ablation procedure
total time for fluoroscopy time
From the beginning till the end of the ablation procedure
Total duration of procedure
Time Frame: From the beginning till the end of the ablation procedure
total time for duration of the procedure
From the beginning till the end of the ablation procedure
(Serious) Adverse Events
Time Frame: Till 12 months
all reported SAEs
Till 12 months
Time to recurrence of AVNRT/WPW-AVRT
Time Frame: up till 12 months
if recurrence of AVNRT/WPW-AVRT, time to recurrence
up till 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Tamas Szili-Torok, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Actual)

March 9, 2020

Study Completion (Anticipated)

March 20, 2021

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL62017.078.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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