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

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

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）

Study Overview

• Status: Completed
• Conditions: AVRT, AVNRT
• Intervention / Treatment: Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University
  • Shandong
    • Qingdao, Shandong, China, 266071
      • The Affiliated Hospital of Qingdao University
  • Shanxi
    • Taiyuan, Shanxi, China, 030024
      • Shanxi Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

300 patients with PSVT who meet eligibility criteria and were ablated with ST catheters will be consecutively enrolled backwards since 02 Nov 2017. Two cohorts are atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT). Each of them contains at least 100 subjects.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AVNRT; atrioventricular nodal reentrant tachycardia	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.
AVRT; atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW）	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute success rate of PSVT ablation using ST Catheter	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.	Intra-procedure
Incidence of primary adverse events (PAE)	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.	From procedure to pre-discharge (an average of 2-3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute success rate of cardiac ablation for AVNRT using ST catheter	defined as accessory pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.	Intra-procedure
Acute success rate of cardiac ablation for AVRT using ST catheter	defined as slow pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.	Intra-procedure
The proportion of patients who did not develop PSVT recurrence	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.	from discharge to the follow-up visit (an average of 4-6 years)
Incidence of serious adverse events	Data can be collected from hospital medical records/database and Telephone Survey Questionnaire.	from discharge to the follow-up visit (an average of 4-6 years)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
• Investigators: Principal Investigator: Haixiong Wang, Professor, Shanxi Cardiovascular Hospital; Principal Investigator: Shanglang Cai, Professor, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: AVRT, AVNRT
• Other Study ID Numbers: BWI_2020_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes