Qubic Stim Cardiac Stimulator in China

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Cardiac Stimulator

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of NanChang University
  • Tianjin
    • Tianjin, Tianjin, China, 300457
      • TEDA International Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	from the intracardiac electrophysiological examination to discharge, an average of three days

Collaborators and Investigators

• Sponsor: Biotronik (Beijing) Medical Device Ltd.
• Investigators: Principal Investigator: Yifeng Zhou, PHD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ventricular arrhythmia; Atrial flutter; Paroxysmal supraventricular tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: EP034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No