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

NCT ID: NCT04923815

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-20

Study Completion Date

2021-12-14

Brief Summary

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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)

Detailed Description

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Conditions

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AVRT, AVNRT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AVNRT

atrioventricular nodal reentrant tachycardia

THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

Intervention Type DEVICE

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.

AVRT

atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome(WPW)

THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Waiver of informed consent is approved by Ethics Committee, or follow methods approved by Ethics Committee to get patient's informed consent (such as get informed consent by telephone contact, etc.).
2. Patients diagnosed as atrioventricular reentrant tachycardia (AVRT), atrioventricular node reentrant tachycardia (AVNRT) after surgery/discharge, and the existing source records must include 1) at least 1 copy of preoperative ECG or intraoperative electrophysiological examination results;2) Information about the acute procedure outcome.
3. Patients were ablated by ST catheter.
4. Adult patients 18 years or older.

Exclusion Criteria

1. Contraindications for the use of ST catheters, including:

1. Ventriculotomy or atriotomy was performed within 8 weeks before the procedure;
2. Presence of myxoma or intracardiac thrombus;
3. fitted with artificial valves;
4. Active systemic infection;
5. Atrial septal patch.
2. Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Medical (Shanghai) Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changsheng Ma, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Haixiong Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Shanxi Cardiovascular Hospital

Shanglang Cai, Professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

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Beijing Anzhen hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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BWI_2020_01

Identifier Type: -

Identifier Source: org_study_id

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