NCT04923815

A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter

A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Paroxysmal supraventricular tachycardia known as PSVT includes atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT). This study is multicenter, retrospective, cohort study. This study will collect real world data of AVNRT and AVRT cohorts retrospectively to evaluate the effectiveness and safety in real world clinical practice. 300 subjects with PSVT will be consecutively enrolled backwards since 02 Nov 2017, and at least 100 subjects for each cohort. Cohort one: AVNRT Cohort two: AVRT, including Wolff-Parkinson-White syndrome（WPW）

Conditions

• AVRT, AVNRT

Interventions

Type	Name	Description
DEVICE	THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter	THERMOCOOL SMARTTOUCH® catheter is a pressure catheter irrigated with cold saline, contact force sensing catheter. When used with Carto ®3 system, this catheter can provide a real time measurement for contact force. The magnitude and direction of the contact force can be displayed visually in the form of vector arrow on the top of catheter in Carto®3 system. It can be used for electrophysiological mapping and ablation of the heart.

Timeline

• Start date: 2021-07-20
• Primary completion: 2021-12-03
• Completion: 2021-12-14
• First posted: 2021-06-11
• Last updated: 2022-02-23

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated device study