Clinical trial NCT04923815: A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter
Official title: A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AVRT, AVNRT
Keywords: AVRT, AVNRT
Lead sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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）


Eligibility criteria: 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

Primary outcomes:
measure: Acute success rate of PSVT ablation using ST Catheter
timeFrame: Intra-procedure
measure: Incidence of primary adverse events (PAE)
timeFrame: From procedure to pre-discharge (an average of 2-3 days)
Secondary outcomes:
measure: Acute success rate of cardiac ablation for AVNRT using ST catheter
timeFrame: Intra-procedure
measure: Acute success rate of cardiac ablation for AVRT using ST catheter
timeFrame: Intra-procedure
measure: The proportion of patients who did not develop PSVT recurrence
timeFrame: from discharge to the follow-up visit (an average of 4-6 years)
measure: Incidence of serious adverse events
timeFrame: from discharge to the follow-up visit (an average of 4-6 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen hospital, Capital Medical University
state: Beijing
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Cardiovascular Hospital
name: Haixiong Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Shanglang Cai, Professor
role: PRINCIPAL_INVESTIGATOR
References: