BradycardiaMICRA-SYNKNCT05817695
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
An observational study of Bradycardia, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bradycardia
- What is being tested?
- Leadless pacemaker
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 May 2023
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients consent to LP implantation surgery
Who may be able to join
- patients consent to LP implantation surgery
Who cannot join
- Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
- Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
- Patients with myocardial infarction;
- Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
- cannot understand or are unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yi zhou XU
Hangzhou, Zhejiang, 310006
Yi zhou XU, +8657156005600, mage0311@163.com
Xiao-fei Gao, +8657188952242, mage0311@126.com
About this study
Official title: Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site
Read the detailed description
Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.
- Conditions
- Bradycardia
- Being tested
- Leadless pacemaker
- Keywords
- Leadless pacing, Synchronization
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless pacemakerDevice
To observe the effect of pacemaker implantation at different sites on cardiac synchronization and tricuspid regurgitation
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of cardiac electrical synchrony
the QRS duration after pacing
Measured: 1 month
The evaluation of cardiac mechanical synchrony
①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond.
②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond，left pre-ejection interval(LPEI) in millisecond.
Measured: 1 month
Secondary outcomes (5)
Age may affect synchronization
Age in years
Measured: 1 month
BMI may affect synchronization
BMI in kg/m^2
Measured: 1 month
Blood pressure may affect synchronization
Systolic and diastolic blood pressure in mmHg
Measured: 1 month
The pacemaker sensing may affect synchronization
pacemaker sensing in millivolt
Measured: 1 month
The pacemaker lead impedance may affect synchronization
lead impedance in ohm
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2022
- Primary completion1 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi zhou XU, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817695
- Sponsor's protocol ID
- MICRA-SYNK-001
- Acronym
- MICRA-SYNK
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT05817695
- Acronym / sponsor ID
- MICRA-SYNK / MICRA-SYNK-001
- Conditions
- Bradycardia
- Keywords
- Leadless pacing, Synchronization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 18 Apr 2023 (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.
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site
Detailed description
Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients consent to LP implantation surgery
Key inclusion criteria (1 listed)
- patients consent to LP implantation surgery
Key exclusion criteria (5 listed)
- Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
- Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
- Patients with myocardial infarction;
- Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
- cannot understand or are unwilling to give informed consent.
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 |
|---|---|---|
| Leadless pacemakerTo observe the effect of pacemaker implantation at different sites on cardiac synchronization and tricuspid regurgitation | Device | – |
Primary outcome
The evaluation of cardiac electrical synchrony
Time frame: 1 month
the QRS duration after pacing
The evaluation of cardiac mechanical synchrony
Time frame: 1 month
①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond. ②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond，left pre-ejection interval(LPEI) in millisecond.
5 secondary outcomes
Age may affect synchronization
Time frame: 1 month
BMI may affect synchronization
Time frame: 1 month
Blood pressure may affect synchronization
Time frame: 1 month
The pacemaker sensing may affect synchronization
Time frame: 1 month
The pacemaker lead impedance may affect synchronization
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Yi zhou XU principal investigator
First People's Hospital of Hangzhou
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, run by First People's Hospital of Hangzhou 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 5 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 18 Apr 2023. 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 Yi zhou XU (+8657156005600, mage0311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of cardiac electrical synchrony (time frame: 1 month). 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 18 Apr 2023.