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

NCT04923815 | Completed FDA Device

• 1 other identifier: BWI_2020_01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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）

Conditions

AVRT, AVNRT

Keywords

AVRT, AVNRT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Acute success rate of cardiac ablation for AVNRT using ST catheter

  Intra-procedure

• Acute success rate of cardiac ablation for AVRT using ST catheter

  Intra-procedure

• The proportion of patients who did not develop PSVT recurrence

  from discharge to the follow-up visit (an average of 4-6 years)

• Incidence of serious adverse events

  from discharge to the follow-up visit (an average of 4-6 years)

Study Arms (2)

AVNRT

atrioventricular nodal reentrant tachycardia

Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

AVRT

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

Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter

Interventions

THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter 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.

AVNRT; AVRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.).
• 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.
• Patients were ablated by ST catheter.
• Adult patients 18 years or older.

You may not qualify if:

• Contraindications for the use of ST catheters, including:
• Ventriculotomy or atriotomy was performed within 8 weeks before the procedure;
• Presence of myxoma or intracardiac thrombus;
• fitted with artificial valves;
• Active systemic infection;
• Atrial septal patch.
• Pregnant women

Sponsors & Collaborators

• Johnson & Johnson Medical (Shanghai) Ltd.: lead

Study Sites (3)

Beijing Anzhen hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030024, China

Location

Study Officials

• Changsheng Ma, Professor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Haixiong Wang, Professor

  Shanxi Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

• Shanglang Cai, Professor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: June 11, 2021
• Study Start: July 20, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 14, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)