Qubic Stim in China

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arrhythmia

Intervention / Treatment
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* Device: Cardiac Stimulator


Participation Criteria
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Eligibility Criteria
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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 atrioventricular 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm ( Qubic Stim Cardiac Stimulator )<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the procedure | 
| High Rate (Burst) | The expected clinical effect: when the tachycardia is induced or terminated by high-rate stimulation, the device can effectively pace the heart at a set rate of stimulation. After the release of electrical stimulation, the stimulation signal can produce an effective cardiac pacing wave. | during the procedure | 
| Measurement of Sinus node recovery time (SNRT) | The expected clinical effect: the sinus node recovery time can be measured. The frequency of the stimulus accelerated step by step and then stopped abruptly.The time interval between the last pacemaker wave and the first recovered sinus atrial wave can be measured. | 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. | from the intracardiac electrophysiological examination to discharge, an average of five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter