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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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