N/A
Completed N=100
Medtronic HAMMOCK Post Approval Study
Source: ClinicalTrials.gov NCT03139721 ↗Enrolled (actual)
100
Serious AEs
62.0%
Results posted
Aug 2024
Primary outcomePrimary: Number of Deaths, Reinterventions, or Explants — 2; 0 Participants
Summary
This study is being conducted to satisfy the post-CE approval requirement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Deaths, Reinterventions, or Explants |
2; 0 | — |
| SECONDARY Mean Gradient (mmHg) |
14.3; 4.6 | — |
| SECONDARY Peak Gradient (mmHg) |
25.6; 11.2 | — |
| SECONDARY Effective Orifice Area (EOA) |
1.41; 1.26 | — |
| SECONDARY Effective Orifice Area Index (EOAi) |
0.71; 0.63 | — |
| SECONDARY Cardiac Output |
4.7; 3.6 | — |
| SECONDARY Cardiac Index |
2.4; 1.8 | — |
| SECONDARY Performance Index |
0.4; 0.2 | — |
| SECONDARY Transvalvular Regurgitation |
50; 4; 1; 4; 1; 1 | — |
| SECONDARY Paravalvular Regurgitation |
46; 9; 1; 0; 4; 0 | — |
| SECONDARY Total Regurgitation |
44; 4; 3; 4; 6; 1 | — |
| SECONDARY New York Heart Association (NYHA) Classification |
51; 7; 14; 1; 1; 1 | — |
| SECONDARY Mean Gradient |
14.3; 5.0 | — |
| SECONDARY Peak Gradient |
26.5; 11.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who require aortic or mitral valve replacement of their native valve.
- Subject is geographically stable and willing to return to the implanting site for all follow-up visits.
- Subject is of legal age to provide informed consent in the country where they enroll in the study.
- Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study.
Exclusion Criteria
- Subject requires concomitant replacement of the aortic and mitral valves.
- Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve.
- Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
Data sourced from ClinicalTrials.gov (NCT03139721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.