Trial Outcomes & Findings for Qubic Stim Cardiac Stimulator in China (NCT NCT04390841)

Last Updated: 2024-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

during the procedure

Results posted on

2024-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	106
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=104 Participants 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.
Age, Continuous	56.39 years STANDARD_DEVIATION 15.38 • n=104 Participants
Sex: Female, Male Female	44 Participants n=104 Participants
Sex: Female, Male Male	60 Participants n=104 Participants
Height	167.61 cm STANDARD_DEVIATION 9.17 • n=70 Participants • Height data were not availiable for 34 of the 104 subjects.
Weight	70.39 kg STANDARD_DEVIATION 12.87 • n=100 Participants • Weight data were not available for 4 of the 104 subjects.
BMI	25.68 kg/m^2 STANDARD_DEVIATION 3.81 • n=70 Participants • BMI data were not available for 34 of the 104 subjects.

PRIMARY outcome

Timeframe: during the procedure

Population: 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.

Outcome measures

Outcome measures
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=104 Participants 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.
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) Exact probability method on the basis of per protocol set (PPS)	100 participants Interval 96.4 to 100.0
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) Asymptotic normal method on the basis of full analysis set (FAS)	98 participants Interval 95.0 to 100.0
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) Exact probability method on the basis of full analysis set (FAS)	98 participants Interval 93.2 to 99.8
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) Asymptotic normal method on the basis of per protocol set (PPS)	100 participants Interval 99.5 to 100.0

PRIMARY outcome

Timeframe: during the procedure

Population: A total of 103 subjects were enrolled in this trial and received high-frequency stimulation from the clinical trial device.

Calculate the percentage of subjects who responded successfully to burst stimulation out of the total number of subjects.

Outcome measures

Outcome measures
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=103 Participants 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.
High Rate (Burst) Stimulating Successful Rate	103 Participants

PRIMARY outcome

Timeframe: during the procedure

Population: A total of 103 subjects were enrolled in this trial and performed SNRT stimulating by the clinical trial device.

Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects.

Outcome measures

Outcome measures
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=103 Participants 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.
Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.	103 Participants

SECONDARY outcome

Timeframe: from the intracardiac electrophysiological examination to discharge, an average of three days

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.

Outcome measures

Outcome measures
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=104 Participants 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.
Serious Device Adverse Events Caused by Cardiac Stimulator	0 Participants

Adverse Events

Single Arm ( Qubic Stim Cardiac Stimulator )

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Arm ( Qubic Stim Cardiac Stimulator ) n=104 participants at risk 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.
Gastrointestinal disorders Intestinal bacteria flora disturbance	0.96% 1/104 • Number of events 1 • 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.
General disorders Fever	0.96% 1/104 • Number of events 1 • 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.
General disorders Distention of constipation	0.96% 1/104 • Number of events 1 • 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.
Hepatobiliary disorders Abnormal liver function	1.9% 2/104 • Number of events 2 • 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.
Cardiac disorders Coronary artery atherosclerosis	0.96% 1/104 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting and nausea	0.96% 1/104 • Number of events 1 • 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.
Infections and infestations Upper respiratory infection	0.96% 1/104 • Number of events 1 • 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.
Cardiac disorders Supraventricular premature beats	0.96% 1/104 • Number of events 1 • 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.
Blood and lymphatic system disorders Blood-stained sputum	0.96% 1/104 • Number of events 1 • 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.
General disorders Headache	0.96% 1/104 • Number of events 1 • 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.
General disorders Dizziness	2.9% 3/104 • Number of events 3 • 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.
Cardiac disorders Elevated markers of myocardial injury	4.8% 5/104 • Number of events 5 • 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.
Cardiac disorders Palpitations	0.96% 1/104 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Chest pain	3.8% 4/104 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders Laryngopharyngitis	0.96% 1/104 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Ecchymosis	0.96% 1/104 • Number of events 1 • 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.
Cardiac disorders Tachycardia sinus	0.96% 1/104 • Number of events 1 • 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.

Additional Information

Senior Clinical Study Project Manager

Biotronik (Beijing) Medical Device Limited

Phone: +86 10 6522 3851-863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER