Status:
COMPLETED
Qubic Stim Cardiac Stimulator in China
Lead Sponsor:
Biotronik (Beijing) Medical Device Ltd.
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
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 Card...
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 c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site.
- 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
- Previous cases of unsuccessful radiofrequency ablation or recurrence
- Pregnant and/or lactating women
- Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination
- Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination
- Obvious bleeding tendency or blood system disease
- Cancer and terminal disease
- Combined with severe organic cardiovascular disease
- Cerebral apoplexy and other cerebrovascular diseases within the past 3 months
- Thromboembolic disease
- Subjects who are participating in other interventional clinical trials
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04390841
Start Date
December 1 2020
End Date
April 12 2021
Last Update
March 12 2024
Active Locations (3)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
3
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China, 300457