Leadless Micra Transcatheter PacemakerNCT05958836
Quality of Life in Patients Treated With Leadless Pacemakers
An observational study of Leadless Micra Transcatheter Pacemaker and Quality of Life, run by Shanghai Zhongshan Hospital.
Trial summary
The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Leadless Micra Transcatheter Pacemaker, Quality of Life
- What is being tested?
- pacemaker
- Type of treatment
- Medical device
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jun 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are eligible if they meet the indication of a single or dual chamber permanent pacemaker. All subjects should fit the following inclusion criteria and disagree with the exclusion criteria.
Who may be able to join
- With an age arranged from 18 to 80 years old;
- Conforming to indication of a pacemaker implantation;
- Life expectancy>1 year;
- Normal cardiac function with preserved LVEF;
- Adequate self-care ability or self-help skills before pacemaker implantation;
- Mentally healthy so as to participate in the quality-of-life assessments;
- Willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
Who cannot join
- Subject with indication for ICD/ CRT-P/CRT-D;
- Subject with persistent symptomatic sinus bradycardia;
- Subject has an existing or prior pacemaker, ICD or CRT device implant;
- Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
- Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
- Subjects with a life expectancy of less than 12-months;
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- Subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure;
- Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence;
- Psychological disorders unable to participate in the quality-of-life assessments.
About this study
Official title: Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers
The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.
- Being tested
- pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemakerDevice
Micra TPS or traditional PM group
| Study group | Role | What they receive |
|---|---|---|
| Micra TPS group | Not described Receives: Device: pacemaker | |
| Traditional PM group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life measured by EQ-5D-5L
The EQ-5D-5L results shall be collected during study follow up visits
Measured: 6 Months post implant
Health-related quality of life measured by NHP (Nottingham Health Profile)
The NHP results shall be collected during study follow up visits
Measured: 6 Months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leadless Micra Transcatheter PacemakerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958836
- Sponsor's protocol ID
- MicraQL
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers
- ClinicalTrials.gov ID
- NCT05958836
- Acronym / sponsor ID
- MicraQL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jul 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.
The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micra TPS group | – | Device: pacemaker |
| Traditional PM group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible if they meet the indication of a single or dual chamber permanent pacemaker. All subjects should fit the following inclusion criteria and disagree with the exclusion criteria.
Key inclusion criteria (7 listed)
- With an age arranged from 18 to 80 years old;
- Conforming to indication of a pacemaker implantation;
- Life expectancy>1 year;
- Normal cardiac function with preserved LVEF;
- Adequate self-care ability or self-help skills before pacemaker implantation;
Key exclusion criteria (9 listed)
- Subject with indication for ICD/ CRT-P/CRT-D;
- Subject with persistent symptomatic sinus bradycardia;
- Subject has an existing or prior pacemaker, ICD or CRT device implant;
- Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
- Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
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 |
|---|---|---|
| pacemakerMicra TPS or traditional PM group | Device | Micra TPS group |
Primary outcome
Health-related quality of life measured by EQ-5D-5L
Time frame: 6 Months post implant
The EQ-5D-5L results shall be collected during study follow up visits
Health-related quality of life measured by NHP (Nottingham Health Profile)
Time frame: 6 Months post implant
The NHP results shall be collected during study follow up visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Leadless Micra Transcatheter Pacemaker and Quality of Life, run by Shanghai Zhongshan Hospital.
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 7 inclusion and 9 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life measured by EQ-5D-5L (time frame: 6 Months post implant). 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 25 Jul 2023.