Arrhythmia
Conditions
Keywords
Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter
Brief 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.
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.
Interventions
DEVICECardiac 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.
Sponsors
Biotronik (Beijing) Medical Device Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site. 3. 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.
Exclusion criteria
1. Previous cases of unsuccessful radiofrequency ablation or recurrence 2. Pregnant and/or lactating women 3. Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination 4. Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination 5. Obvious bleeding tendency or blood system disease 6. Cancer and terminal disease 7. Combined with severe organic cardiovascular disease 8. Cerebral apoplexy and other cerebrovascular diseases within the past 3 months 9. Thromboembolic disease 10. Subjects who are participating in other interventional clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) | 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 | 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. | during the procedure | Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Device Adverse Events Caused by Cardiac Stimulator | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Single Arm ( Qubic Stim Cardiac Stimulator ) | — |
|---|---|---|
| Age, Continuous | 56.39 years STANDARD_DEVIATION 15.38 | — |
| BMI | 25.68 kg/m^2 STANDARD_DEVIATION 3.81 | — |
| Height | 167.61 cm STANDARD_DEVIATION 9.17 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 60 Participants | — |
| Weight | 70.39 kg STANDARD_DEVIATION 12.87 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 104 |
| other Total, other adverse events | 19 / 104 |
| serious Total, serious adverse events | 0 / 104 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) | Asymptotic normal method on the basis of full analysis set (FAS) | 98 participants |
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) | Exact probability method on the basis of full analysis set (FAS) | 98 participants |
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) | Asymptotic normal method on the basis of per protocol set (PPS) | 100 participants |
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) | Exact probability method on the basis of per protocol set (PPS) | 100 participants |
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.
Time frame: during the procedure
Population: A total of 103 subjects were enrolled in this trial and received high-frequency stimulation from the clinical trial device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | High Rate (Burst) Stimulating Successful Rate | 103 Participants |
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.
Time frame: during the procedure
Population: A total of 103 subjects were enrolled in this trial and performed SNRT stimulating by the clinical trial device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured. | 103 Participants |
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.
Time frame: from the intracardiac electrophysiological examination to discharge, an average of three days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm ( Qubic Stim Cardiac Stimulator ) | Serious Device Adverse Events Caused by Cardiac Stimulator | 0 Participants |