Trials / Completed
CompletedNCT03624504
China Micra Transcatheter Pacing Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Micra Transcatheter Pacing System (TPS) | Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2019-08-29
- Completion
- 2020-01-20
- First posted
- 2018-08-10
- Last updated
- 2020-09-30
- Results posted
- 2020-09-30
Locations
7 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03624504. Inclusion in this directory is not an endorsement.