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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04078685
Other study ID # NL62017.078.17
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 12, 2018
Est. completion date March 20, 2021

Study information

Verified date September 2020
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Standard catheter ablation
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
Contact Force-sensing-based catheter ablation
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter

Locations

Country Name City State
Netherlands Erasmus MC Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Fluoroscopy time total time for fluoroscopy time From the beginning till the end of the ablation procedure
Secondary Total duration of procedure total time for duration of the procedure From the beginning till the end of the ablation procedure
Secondary (Serious) Adverse Events all reported SAEs Till 12 months
Secondary Time to recurrence of AVNRT/WPW-AVRT if recurrence of AVNRT/WPW-AVRT, time to recurrence up till 12 months
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