NCT04390841

Qubic Stim Cardiac Stimulator in China

Completed NA Results posted Last updated 12 March 2024

What this trial tests

NA trial testing Cardiac Stimulator in Arrhythmia in 106 participants. Completed in 12 April 2021.

Timeline

1 December 2020

Primary endpoint
7 April 2021

12 April 2021

Quick facts

Lead sponsor	Biotronik (Beijing) Medical Device Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	106
Start date	1 December 2020
Primary completion	7 April 2021
Estimated completion	12 April 2021
Sites	3 locations across China

Drugs / interventions tested

• Cardiac Stimulator

Conditions studied

• Arrhythmia — all drugs for Arrhythmia →

Sponsor

Biotronik (Beijing) Medical Device Ltd.

Who can join

18 and older, any sex, with Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) Primary · 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 statisti

Asymptotic normal method on the basis of full analysis set (FAS)

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	98	95 – 100

Exact probability method on the basis of full analysis set (FAS)

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	98	93.2 – 99.8

Asymptotic normal method on the basis of per protocol set (PPS)

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	100	99.5 – 100

Exact probability method on the basis of per protocol set (PPS)

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	100	96.4 – 100

High Rate (Burst) Stimulating Successful Rate Primary · during the procedure

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

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	103

Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured. Primary · during the procedure

Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects.

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	103

Serious Device Adverse Events Caused by Cardiac Stimulator Secondary · 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.

Group	Value	95% CI
Single Arm ( Qubic Stim Cardiac Stimulator )	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Collect the adverse event data from the time when subjects signed the informed consent form until they were discharged from the hospital, which typically takes an average of 3 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm ( Qubic Stim Cardiac Stimulator )

Serious: 0/104 (0%)

Deaths: 0/104

Other adverse events (17 terms — click to expand)

Reaction	System	Single Arm ( Qubic Stim Ca…
Elevated markers of myocardial injury	Cardiac disorders	—
Chest pain	Respiratory, thoracic and mediastinal disorders	—
Dizziness	General disorders	—
Abnormal liver function	Hepatobiliary disorders	—
Intestinal bacteria flora disturbance	Gastrointestinal disorders	—
Fever	General disorders	—
Distention of constipation	General disorders	—
Coronary artery atherosclerosis	Cardiac disorders	—
Vomiting and nausea	Gastrointestinal disorders	—
Upper respiratory infection	Infections and infestations	—
Supraventricular premature beats	Cardiac disorders	—
Blood-stained sputum	Blood and lymphatic system disorders	—
Headache	General disorders	—
Palpitations	Cardiac disorders	—
Laryngopharyngitis	Respiratory, thoracic and mediastinal disorders	—
Ecchymosis	Skin and subcutaneous tissue disorders	—
Tachycardia sinus	Cardiac disorders	—

Data from ClinicalTrials.gov NCT04390841 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.