Trials / Completed
CompletedNCT04915924
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 358 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HeartMate 3™ left ventricular assist system (HM3 LVAS) | Advanced heart failure patients will be implanted with the HM3 LVAS |
Timeline
- Start date
- 2020-10-30
- Primary completion
- 2024-06-02
- Completion
- 2024-06-02
- First posted
- 2021-06-07
- Last updated
- 2024-07-30
Locations
22 sites across 1 country: South Korea
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04915924. Inclusion in this directory is not an endorsement.