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

Completed

• Conditions: AVRT, AVNRT
• Interventions: Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

• Registration Number: NCT04923815
• Lead Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.

Brief 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）

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-11
• Study Start: 2021-07-20
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AVRT	THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter	atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW）
AVNRT	THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter	atrioventricular nodal reentrant tachycardia

Primary Outcome Measures

Name	Time	Method
Incidence of primary adverse events (PAE)	From procedure to pre-discharge (an average of 2-3 days)	Primary adverse events include device or procedure related death, myocardial infarction, atrioventricular block, thrombosis, stroke/cerebral vascular accidents (CVA), tamponade/perforation, transient ischemia attack (TIA), pericarditis, major vascular complications/bleeding, Adverse Event which prolonged hospitalization due to non-arrhythmic causes.
Acute success rate of PSVT ablation using ST Catheter	Intra-procedure	Acute success rate is defined as accessory pathway/slow pathway blockade immediately after ablation, and drug and/or electrophysiological stimulation no longer induces clinical arrhythmias.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients who did not develop PSVT recurrence	from discharge to the follow-up visit (an average of 4-6 years)	Data can be collected from hospital medical records/database and Telephone Survey Questionnaire. Recurrence of PSVT includes recurrence of PSVT identified by electrocardiogram or other cardio-electrical equipment, re-admission due to PSVT, re-procedure due to PSVT, take anti-arrhythmic drug due to PSVT, suffering typical PSVT symptoms.
Incidence of serious adverse events	from discharge to the follow-up visit (an average of 4-6 years)	Data can be collected from hospital medical records/database and Telephone Survey Questionnaire.
Acute success rate of cardiac ablation for AVNRT using ST catheter	Intra-procedure	defined as accessory pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.
Acute success rate of cardiac ablation for AVRT using ST catheter	Intra-procedure	defined as slow pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.

Trial Locations

Locations (3)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Shanxi Cardiovascular Hospital; 🇨🇳 Taiyuan, Shanxi, China

Beijing Anzhen hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China