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China Micra Transcatheter Pacing Study

NCT03624504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2020-09-30

Study results available
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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.

Conditions

  • Bradycardia

Interventions

DEVICE

Micra Transcatheter Pacing System (TPS)

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

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Shu Zhang, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-08-29
Completion
2020-01-20
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624504 on ClinicalTrials.gov