Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yifeng Zhou, PHD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| The First Affiliated Hospital of Nanchang University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm ( Qubic Stim Cardiac Stimulator ) | 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. Cardiac Stimulator: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm ( Qubic Stim Cardiac Stimulator ) | 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. Cardiac Stimulator: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 106 subjects were enrolled in this trial. There were 2 patients excluded from FAS because withdrew informed consent and not complete intracardiac electrophysiological examination with the study device. There remaining 104 patients were included in FAS. In addition, 2 subjects were excluded from PPS because they did not complete all the six required items during the intracardiac electrophysiological examination according to the protocol. Consequently, 102 patients were included in PPS. | Posted | Number | 95% Confidence Interval | participants | during the procedure |
Collect the adverse event data from the time when subjects signed the informed consent form until they were discharged from the hospital, which typically takes an average of 3 days.
Adverse event (AE) refers to any untoward medical occurrence, accident disease or injury, adverse clinical event. All events related to medical device and surgery are included. The symptom occurred due to the existing condition or disease before the enrollment of subjects are not considered to be AE if its frequency of occurrence or severity is not changed.
The planned examination that doesn't damage the health of subjects, such as regular screening for cancer, is not considered to be AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm ( Qubic Stim Cardiac Stimulator ) | 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. Cardiac Stimulator: 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal bacteria flora disturbance | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Study Project Manager | Biotronik (Beijing) Medical Device Limited | +86 10 6522 3851-863 | lan.chen@biotronik.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2020 | Dec 6, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D017180 | Tachycardia, Ventricular |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| from the intracardiac electrophysiological examination to discharge, an average of three days |
| Nanchang |
| Jiangxi |
| China |
| TEDA International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Height data were not availiable for 34 of the 104 subjects. | Mean | Standard Deviation | cm |
|
| Weight | Weight data were not available for 4 of the 104 subjects. | Mean | Standard Deviation | kg |
|
| BMI | BMI data were not available for 34 of the 104 subjects. | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Primary | High Rate (Burst) Stimulating Successful Rate | Calculate the percentage of subjects who responded successfully to burst stimulation out of the total number of subjects. | A total of 103 subjects were enrolled in this trial and received high-frequency stimulation from the clinical trial device. | Posted | Count of Participants | Participants | during the procedure |
|
|
|
| Primary | 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. | A total of 103 subjects were enrolled in this trial and performed SNRT stimulating by the clinical trial device. | Posted | Count of Participants | Participants | during the procedure |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | from the intracardiac electrophysiological examination to discharge, an average of three days |
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 19 |
| 104 |
| Fever | General disorders | Systematic Assessment |
|
| Distention of constipation | General disorders | Systematic Assessment |
|
| Abnormal liver function | Hepatobiliary disorders | Systematic Assessment |
|
| Coronary artery atherosclerosis | Cardiac disorders | Systematic Assessment |
|
| Vomiting and nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Supraventricular premature beats | Cardiac disorders | Systematic Assessment |
|
| Blood-stained sputum | Blood and lymphatic system disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Elevated markers of myocardial injury | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Laryngopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tachycardia sinus | Cardiac disorders | Systematic Assessment |
|
The sponsor has exclusive ownership of the trial data and results. During the clinical trial, the sponsor has the right to access and use all data and results of the trial. Individual clinical trial centers are not allowed to publish and/or report their results until the results of all center are published and/or reported. The sponsor agrees that the leading investigators of the trial will publish the results of the clinical trial.
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |