ArrhythmiaNCT04390841
Qubic Stim Cardiac Stimulator in China
A study testing Cardiac Stimulator in people with Arrhythmia, run by Biotronik (Beijing) Medical Device Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Cardiac Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2020to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
About this study
Official title: Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator
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.
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- Cardiac Stimulator
- Keywords
- Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter
- Medical subject headings
- Arrhythmias, Cardiac, Tachycardia, Ventricular, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac StimulatorDevice
The subjects 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Experimental | 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. Receives: Device: Cardiac Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)
The expected clinical effect: the heart is effectively paced by PES at a set rate of stimulation.
After the release of electrical stimulation, the stimulation signal can produce an effective cardiac pacing wave.
The asymptotic normal method is an estimator whose limiting distribution is normal when the sample size n increases indefinitely. For example, the sample mean and sample moment are asymptotically normal estimators. Under a wide range of conditions, the maximum likelihood estimators of unknown parameters are asymptotically normal estimators.
The exact probability method is a statistical test used to determine whether there is a non-random correlation between two variables.
The asymptotic normal method and the exact probability method were used to estimate the 95% confidence interval of success rate of diagnostic electrical stimulation performed by heart stimulator.
Measured: during the procedure
High Rate (Burst) Stimulating Successful Rate
Calculate the percentage of subjects who responded successfully to burst stimulation out of the total number of subjects.
Measured: during the procedure
Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.
Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects.
Measured: during the procedure
Secondary outcomes (1)
Serious Device Adverse Events Caused by Cardiac Stimulator
All adverse events shall be recorded throughout the study. However, only the serious adverse events that are definitely, likely or possibly related to Qubic Stim cardiac stimulator will become the basis of SADE event rate. The number of participants with Serious device adverse events caused by cardiac stimulator will be measured and reported.
Measured: from the intracardiac electrophysiological examination to discharge, an average of three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Dec 2020
- Primary completion7 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifeng Zhou, PHD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390841
- Sponsor's protocol ID
- EP034
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator
- ClinicalTrials.gov ID
- NCT04390841
- Acronym / sponsor ID
- EP034
- Conditions
- Arrhythmia
- Keywords
- Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Experimental | Device: Cardiac StimulatorThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac StimulatorThe subjects 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. | Device | Single Arm ( Qubic Stim Cardiac Stimulator ) |
Primary outcome
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)
Time frame: during the procedure
The expected clinical effect: the heart is effectively paced by PES at a set rate of stimulation. After the release of electrical stimulation, the stimulation signal can produce an effective cardiac pacing wave. The asymptotic normal method is an estimator whose limiting distribution is normal when the sample size n increases indefinitely. For example, the sample mean and sample moment are asymptotically normal estimators. Under a wide range of conditions, the maximum likelihood estimators of unknown parameters are asymptotically normal estimators. The exact probability method is a statistical test used to determine whether there is a non-random correlation between two variables. The asymptotic normal method and the exact probability method were used to estimate the 95% confidence interval of success rate of diagnostic electrical stimulation performed by heart stimulator.
High Rate (Burst) Stimulating Successful Rate
Time frame: during the procedure
Calculate the percentage of subjects who responded successfully to burst stimulation out of the total number of subjects.
Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.
Time frame: during the procedure
Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects.
1 secondary outcome
Serious Device Adverse Events Caused by Cardiac Stimulator
Time frame: from the intracardiac electrophysiological examination to discharge, an average of three days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yifeng Zhou, PHD principal investigator
China-Japan Friendship Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Stimulator in people with Arrhythmia, run by Biotronik (Beijing) Medical Device Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) (time frame: during the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.