N/A
Completed N=82
China Micra Transcatheter Pacing Study
Bradycardia
Source: ClinicalTrials.gov NCT03624504 ↗
Enrolled (actual)
82
Serious AEs
14.6%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Participants With Major Complications Free Survival Probability — 97.6 percentage of participants — p=0.0021
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Complications Free Survival Probability |
97.6 | 0.0021 sig |
| SECONDARY Pacing Capture Threshold (PCT) |
0.52; 0.52; 0.50; 0.47; 0.50 | — |
| SECONDARY Impedance |
873.83; 781.73; 719.38; 659.01; 632.22 | — |
| SECONDARY Sensing Amplitude |
9.41; 11.16; 13.53; 13.78; 13.87 | — |
| SECONDARY Adverse Device Effect |
1; 1; 3; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03624504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.