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Completed

NCT Number: NCT04390841

Qubic Stim Cardiac Stimulator in China

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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

  • Previous cases of unsuccessful radiofrequency ablation or recurrence
  • Pregnant and/or lactating women
  • Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination
  • Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination
  • Obvious bleeding tendency or blood system disease
  • Cancer and terminal disease
  • Combined with severe organic cardiovascular disease
  • Cerebral apoplexy and other cerebrovascular diseases within the past 3 months
  • Thromboembolic disease
  • Subjects who are participating in other interventional clinical trials

Treatment and study plan

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.

Primary outcomes

  1. Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)

    Time frame: 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.

  2. High Rate (Burst) Stimulating Successful Rate

    Time frame: during the procedure

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

  3. Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.

    Time frame: 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 outcomes

  1. Serious Device Adverse Events Caused by Cardiac Stimulator

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biotronik (Beijing) Medical Device Ltd.

Industry

Registry information

Official study title

Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 18, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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