search
Back to results

Qubic Stim in China

Primary Purpose

Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cardiac Stimulator
Sponsored by
Biotronik (Beijing) Medical Device Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmia focused on measuring Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site.
  3. 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:

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

Sites / Locations

  • China-Japan Friendship Hospital
  • The First Affiliated Hospital of Nanchang University
  • TEDA International Cardiovascular Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm ( Qubic Stim Cardiac Stimulator )

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 24, 2020
Last Updated
April 21, 2021
Sponsor
Biotronik (Beijing) Medical Device Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04390841
Brief Title
Qubic Stim in China
Official Title
Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
April 7, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik (Beijing) Medical Device Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Paroxysmal supraventricular tachycardia, Ventricular arrhythmia, Atrial fibrillation, Atrial flutter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm ( Qubic Stim Cardiac Stimulator )
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cardiac Stimulator
Intervention Description
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 Outcome Measure Information:
Title
Programmed extrastimulation (PES)
Description
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.
Time Frame
during the procedure
Title
High Rate (Burst)
Description
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.
Time Frame
during the procedure
Title
Measurement of Sinus node recovery time (SNRT)
Description
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.
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Serious device adverse events caused by cardiac stimulator
Description
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.
Time Frame
from the intracardiac electrophysiological examination to discharge, an average of five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifeng Zhou, PHD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
TEDA International Cardiovascular Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300457
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Qubic Stim in China

We'll reach out to this number within 24 hrs