Trials / Completed
CompletedNCT02444338
A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation
Randomised Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients With Clinically Significant Functional Mitral Regurgitation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 505 (actual)
- Sponsor
- University Medical Center Goettingen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.
Detailed description
The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MitraClip | Implantation of the MitraClip System for patients with chronic heart failure. |
| OTHER | standard of care |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2024-04-19
- Completion
- 2024-04-19
- First posted
- 2015-05-14
- Last updated
- 2024-09-19
Locations
35 sites across 9 countries: Czechia, Denmark, Germany, Greece, Italy, Poland, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02444338. Inclusion in this directory is not an endorsement.