Qubic Stim Cardiac Stimulator in China

Not Applicable

Completed

• Conditions: Arrhythmia
• Interventions: Device: Cardiac Stimulator

• Registration Number: NCT04390841
• Lead Sponsor: Biotronik (Beijing) Medical Device Ltd.

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.

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-18
• Study Start: 2020-12-01
• Primary Completion: 2021-04-07
• Study Completion: 2021-04-12
• Results First Submitted: 2021-12-06
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm ( Qubic Stim Cardiac Stimulator )	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, Tianjin, China