Qubic Stim Cardiac Stimulator in China

NCT04390841 | Completed Results

• 1 other identifier: EP034
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Arrhythmia

Keywords

Paroxysmal supraventricular tachycardia; Ventricular arrhythmia; Atrial fibrillation; Atrial flutter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Serious Device Adverse Events Caused by Cardiac Stimulator

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

Study Arms (1)

Single Arm ( Qubic Stim Cardiac Stimulator )

EXPERIMENTAL

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

Interventions

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.

Single Arm ( Qubic Stim Cardiac Stimulator )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik (Beijing) Medical Device Ltd.: lead

Study Sites (3)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular; Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Senior Clinical Study Project Manager
• Organization: Biotronik (Beijing) Medical Device Limited

lan.chen@biotronik.com

+86 10 6522 3851-863

Study Officials

• Yifeng Zhou, PHD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: May 18, 2020
• Study Start: December 1, 2020
• Primary Completion: April 7, 2021
• Study Completion: April 12, 2021
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)