China Micra Transcatheter Pacing Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2020-01-20

Brief Summary

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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.

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Detailed Description

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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

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Bradycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Micra Implant Group

Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)

Group Type EXPERIMENTAL

Micra Transcatheter Pacing System (TPS)

Intervention Type DEVICE

Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements

Interventions

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Micra Transcatheter Pacing System (TPS)

Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. Subjects who are at least 18 years of age.

Exclusion Criteria

1. Subject has an existing or prior pacemaker, ICD or CRT device implant.
2. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
3. 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.
4. Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
5. Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
6. 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.
7. Subjects who are considered as unable to tolerate an urgent sternotomy.
8. Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
9. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
10. Subjects with a life expectancy of less than 12-months.
11. 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.
12. 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.
14. Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No