Trials / Active Not Recruiting
Active Not RecruitingNCT01757665
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 777 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
Detailed description
Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M | Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M |
Timeline
- Start date
- 2012-12-11
- Primary completion
- 2017-08-01
- Completion
- 2026-08-01
- First posted
- 2012-12-31
- Last updated
- 2025-11-17
- Results posted
- 2019-12-27
Locations
32 sites across 3 countries: United States, Canada, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01757665. Inclusion in this directory is not an endorsement.