CompletedNot Applicable

Qubic Stim Cardiac Stimulator in China

China106 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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):

Exclusion criteria

✕. 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

What they're measuring

Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)

Timeframe: during the procedure

High Rate (Burst) Stimulating Successful Rate

Timeframe: during the procedure

Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.

Timeframe: during the procedure

Trial details

NCT IDNCT04390841

SponsorBiotronik (Beijing) Medical Device Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-07

Results submitted2021-12-06

View on ClinicalTrials.gov More Arrhythmia trials