Qubic Stim Cardiac Stimulator in China

Biotronik

Status: Completed

Conditions: Arrhythmia

Treatments: Device: Cardiac Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390841

EP034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Single Arm ( Qubic Stim Cardiac Stimulator )

Experimental group

Description:

There is only one Arm in this trial, 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.

Treatment:

Device: Cardiac Stimulator