Trials / Terminated
TerminatedNCT04703855
Hong Kong and Taiwan HM3 PMS
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, 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 approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
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
- 2021-07-14
- Primary completion
- 2022-03-31
- Completion
- 2022-06-30
- First posted
- 2021-01-11
- Last updated
- 2024-07-01
- Results posted
- 2024-07-01
Locations
3 sites across 2 countries: Hong Kong, Taiwan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04703855. Inclusion in this directory is not an endorsement.