Clinical trial NCT04390841: Qubic Stim Cardiac Stimulator in China
Official title: Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: Paroxysmal supraventricular tachycardia
Ventricular arrhythmia
Atrial fibrillation
Atrial flutter
Lead sponsor: Biotronik (Beijing) Medical Device Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population.

Detailed description: The trial is a multicenter, prospective and single-arm study. 106 appropriate subjects were selected from 3 study sites in China in accordance with the inclusion and exclusion criteria. The subjects consent to participate in the trial and sign the informed consent. The subjects who meet the inclusion and exclusion criteria will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the Qubic Stim Cardiac Stimulator. The subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital. The clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population were proved by observing the data collected in this study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site.
3. Subjects with an indication of the intracardiac electrophysiological examination(fit one of the following):

   * Paroxysmal supraventricular tachycardia: atrioventricular reentrant tachycardia or atrioventricular node reentrant tachycardia or atrial tachycardia.
   * Ventricular arrhythmia: Premature ventricular contraction or ventricular tachycardia.
   * Atrial fibrillation.
   * Atrial flutter.

Exclusion Criteria:

1. Previous cases of unsuccessful radiofrequency ablation or recurrence
2. Pregnant and/or lactating women
3. Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination
4. Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination
5. Obvious bleeding tendency or blood system disease
6. Cancer and terminal disease
7. Combined with severe organic cardiovascular disease
8. Cerebral apoplexy and other cerebrovascular diseases within the past 3 months
9. Thromboembolic disease
10. Subjects who are participating in other interventional clinical trials

Primary outcomes:
measure: Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)
timeFrame: during the procedure
measure: High Rate (Burst) Stimulating Successful Rate
timeFrame: during the procedure
measure: Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.
timeFrame: during the procedure
Secondary outcomes:
measure: Serious Device Adverse Events Caused by Cardiac Stimulator
timeFrame: from the intracardiac electrophysiological examination to discharge, an average of three days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
state: Tianjin
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yifeng Zhou, PHD
role: PRINCIPAL_INVESTIGATOR
References: