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

Johnson & Johnson Medical (Shanghai) Ltd.300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

AVRT, AVNRT

Interventions

THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip CatheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Beijing Anzhen hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From procedure to pre-discharge (an average of 2-3 days)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Incidence of serious adverse events

Data from ClinicalTrials.gov

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