Trials / Terminated
TerminatedNCT02351726
Mitroflow DL Post Approval Study- North America
Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
Detailed description
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic heart valves. The study will be conducted in a minimum of 15 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and annually for 8 years. The duration of the study is anticipated to be 8 years.
Conditions
- Aortic Stenosis
- Aortic Regurgitation
- Aortic Valve Insufficiency
- Heart Valve Diseases
- Cardiovascular Abnormalities
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Diseases
- Pathological Conditions, Anatomical
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mitroflow DL | Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2015-01-30
- Last updated
- 2020-02-20
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02351726. Inclusion in this directory is not an endorsement.