BradycardiaNCT03624504
China Micra Transcatheter Pacing Study
A study testing Micra Transcatheter Pacing System (TPS) in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in China.
Trial summary
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for regulatory approval in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Micra Transcatheter Pacing System (TPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesChina
- Study dates
- 31 Jul 2018to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and China guideline.
- Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
- Subjects who are at least 18 years of age.
Who cannot join
- Subject has an existing or prior pacemaker, ICD or CRT device implant.
- Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
- Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
- Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
- Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
- Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
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- Subjects who are considered as unable to tolerate an urgent sternotomy.
- Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
- Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
- Subjects with a life expectancy of less than 12-months.
- Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
- 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.
- Subjects with exclusion criteria required by local law (age or other).
- Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Second Affliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200005
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for regulatory approval in China.
Read the detailed description
All study sites will be in China. Subjects successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. The overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.
- Conditions
- Bradycardia
- Being tested
- Micra Transcatheter Pacing System (TPS)
- Keywords
- Transcatheter Pacing System, Micra Implantable Device, Transfermoral Catheter Delivery System
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micra Transcatheter Pacing System (TPS)Device
Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
| Study group | Role | What they receive |
|---|---|---|
| Micra Implant Group | Experimental | Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Receives: Device: Micra Transcatheter Pacing System (TPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Major Complications Free Survival Probability
Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant
Measured: 6 months post implant
Secondary outcomes (4)
Pacing Capture Threshold (PCT)
Pacing capture threshold @0.24ms pulse width Capture threshold is defined as the minimum electrical stimulus required to consistently capture the heart outside of the myocardial refractory period.
Pulse width is the duration of the current flow expressed in milliseconds. The pulse width must be long enough for depolarization to disperse to the surrounding tissue.
Measured: Implant, Discharge, Month 1, Month 3, Month 6
Impedance
Impedance measured from the Micra device Impedance is the opposition to current flow.
Measured: Implant, Discharge, Month 1, Month 3, Month 6
Sensing Amplitude
R-wave sensing amplitude measured from the Micra device Sensing is the ability of the pacemaker to "see" when a natural (intrinsic) depolarization is occurring.
Measured: Implant, Discharge, Month 1, Month 3, Month 6
Adverse Device Effect
Adverse event related to the Micra system or implant procedure
Measured: From implant attempt to last subject follow-up, ranging from 0 to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start31 Jul 2018
- Primary completion29 Aug 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shu Zhang, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624504
- Sponsor's protocol ID
- China Micra
- Status last verified
- Sep 2020
- First submitted
- 13 Jul 2018
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Micra Transcatheter Pacing Study
- ClinicalTrials.gov ID
- NCT03624504
- Acronym / sponsor ID
- China Micra
- Conditions
- Bradycardia
- Keywords
- Transcatheter Pacing System, Micra Implantable Device, Transfermoral Catheter Delivery System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for regulatory approval in China.
Detailed description
All study sites will be in China. Subjects successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. The overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Micra Implant Group | Experimental | Device: Micra Transcatheter Pacing System (TPS)Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and China guideline.
- Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
- Subjects who are at least 18 years of age.
Key exclusion criteria (14 listed)
- Subject has an existing or prior pacemaker, ICD or CRT device implant.
- Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
- Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
- Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
- Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
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 |
|---|---|---|
| Micra Transcatheter Pacing System (TPS)Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements | Device | Micra Implant Group |
Primary outcome
Percentage of Participants With Major Complications Free Survival Probability
Time frame: 6 months post implant
Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant
4 secondary outcomes
Pacing Capture Threshold (PCT)
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Impedance
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Sensing Amplitude
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Adverse Device Effect
Time frame: From implant attempt to last subject follow-up, ranging from 0 to 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shu Zhang, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micra Transcatheter Pacing System (TPS) in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Major Complications Free Survival Probability (time frame: 6 months post implant). 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 30 Sep 2020.