Trials / Completed
CompletedNCT03107455
MitraClip in Acute Mitral Regurgitation
European Registry of MitraClip in Acute Myocardial Infarction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Fundación Investigación Sanitaria en León · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MitraClip | MitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-07-01
- Completion
- 2021-12-01
- First posted
- 2017-04-11
- Last updated
- 2022-03-16
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03107455. Inclusion in this directory is not an endorsement.