Medtronic HAMMOCK Post Approval Study
- Conditions
- Heart Valve Diseases
- Registration Number
- NCT03139721
- Lead Sponsor
- Medtronic Cardiac Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Subjects who require aortic or mitral valve replacement of their native valve.<br><br> 2. Subject is geographically stable and willing to return to the implanting site for<br> all follow-up visits.<br><br> 3. Subject is of legal age to provide informed consent in the country where they enroll<br> in the study.<br><br> 4. Subject has been adequately informed of risks and requirements of the study and is<br> willing and able to provide informed consent for participation in the clinical<br> study.<br><br>Exclusion Criteria:<br><br> 1. Subject requires concomitant replacement of the aortic and mitral valves.<br><br> 2. Subject requires a replacement of a previously implanted prosthetic aortic or mitral<br> valve.<br><br> 3. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Deaths, Reinterventions, or Explants;Number of Deaths, Reinterventions, or Explants
- Secondary Outcome Measures
Name Time Method Mean Gradient (mmHg);Peak Gradient (mmHg);Effective Orifice Area (EOA);Effective Orifice Area Index (EOAi);Cardiac Output;Cardiac Index;Performance Index;Transvalvular Regurgitation;Paravalvular Regurgitation;Total Regurgitation;New York Heart Association (NYHA) Classification;Mean Gradient;Peak Gradient;Effective Orifice Area (EOA);Effective Orifice Area Index (EOAi);Cardiac Output;Cardiac Index;Performance Index;Transvalvular Regurgitation;Paravalvular Regurgitation;Total Regurgitation;New York Heart Association (NYHA) Classification