Bradycardia; SyncopeNCT04905199
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
An observational study of Bradycardia; Syncope and Bradyarrhythmia, run by Hunan Provincial People's Hospital at 1 site in China.
Trial summary
Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bradycardia; Syncope, Bradyarrhythmia, Brady-tachy Syndrome
- What is being tested?
- Temporary transvenous cardiac pacing
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients need emergency or selective temporary pacing.
Who may be able to join
- Patients with indication of temporary transvenous pacing
Who cannot join
- Not applicate to IC-ECG monitoring.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincial People's hospital
Changsha, Hunan, 410000
Jie Zhong, MD, +8673182278047, kybgcp@163.com
About this study
Official title: Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.
Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.
Read more
Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) > V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)<V(+) indicates tip directs to outflow tract.
The investigators hypothesis this monitoring will help precisely placement.
- Conditions
- Bradycardia; Syncope, Bradyarrhythmia, Brady-tachy Syndrome, Tachycardia Bradycardia, AVB - Atrioventricular Block, Tachyarrhythmia
- Being tested
- Temporary transvenous cardiac pacing
- Medical subject headings
- Bradycardia, Syncope, Atrioventricular Block, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary transvenous cardiac pacingProcedure or surgery
Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Non-floating catheter | When using non-floating catheter. Receives: Procedure: Temporary transvenous cardiac pacing | |
| Floating catheter | When using floating catheter. Receives: Procedure: Temporary transvenous cardiac pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacer leads location
Satisfy location is in the apex of the right ventricle.
Measured: One day.
Catheter-related complications
Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.
Measured: One month.
Secondary outcomes (1)
Other complications
Complications not relate to pacing catheter.
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start25 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bradycardia; SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Liu, Hunan Provincial People's Hospital
- Investigators
- Xiaotong Han, MD, Study director, Hunan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905199
- Sponsor's protocol ID
- 202084
- Status last verified
- Nov 2021
- First submitted
- 25 May 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any date will share if appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
- ClinicalTrials.gov ID
- NCT04905199
- Acronym / sponsor ID
- 202084
- Conditions
- Bradycardia; Syncope, Bradyarrhythmia, Brady-tachy Syndrome, Tachycardia Bradycardia, AVB - Atrioventricular Block, Tachyarrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hunan Provincial People's HospitalUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.
Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.
Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) > V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)<V(+) indicates tip directs to outflow tract.
The investigators hypothesis this monitoring will help precisely placement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-floating catheter | – | Procedure: Temporary transvenous cardiac pacingWhen using non-floating catheter. |
| Floating catheter | – | Procedure: Temporary transvenous cardiac pacingWhen using floating catheter. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients need emergency or selective temporary pacing.
Key inclusion criteria (1 listed)
- Patients with indication of temporary transvenous pacing
Key exclusion criteria (1 listed)
- Not applicate to IC-ECG monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary transvenous cardiac pacingTransvenous temporary pacemaker insertion by modified IC-ECG monitoring. | Procedure or surgery | Floating catheter, Non-floating catheter |
Primary outcome
Pacer leads location
Time frame: One day.
Satisfy location is in the apex of the right ventricle.
Catheter-related complications
Time frame: One month.
Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.
1 secondary outcome
Other complications
Time frame: One month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: Yes. Any date will share if appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaotong Han, MD study director
Hunan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia; Syncope and Bradyarrhythmia, run by Hunan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Liu, MD (+8615084858606, 183578012@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pacer leads location (time frame: One day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.