N/A Completed N=106 Diagnostic

Qubic Stim Cardiac Stimulator in China

Arrhythmias

Source: ClinicalTrials.gov NCT04390841 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcomePrimary: Count of Participants With Paced Successfully by Programmed Extrastimulation (PES) — 98; 98; 100; 100 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)	98; 98; 100; 100	—
PRIMARY High Rate (Burst) Stimulating Successful Rate	103	—
PRIMARY Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.	103	—
SECONDARY Serious Device Adverse Events Caused by Cardiac Stimulator	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04390841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.