A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter (ST in PSVT-RWS)

Johnson & Johnson (J&J)

Status: Completed

Conditions: AVRT, AVNRT

Treatments: Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04923815

BWI_2020_01

Details and patient eligibility

About

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）

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

AVNRT

Description:

atrioventricular nodal reentrant tachycardia

Treatment:

Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

AVRT

Description:

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

Treatment:

Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter