heart failure Heart valve disease
Conditions
Interventions
None listed
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is expected to undergo cardiac surgery in
Exclusion criteria
Exclusion criteria: 1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent. 2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 3. Subject is expected to have or had active endocarditis at the time of their Abbott annuloplasty device implant(s). 4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s). 5. Subject is participating in another clinical investigation including any treatment outside the investigative site*s usual standard of care. 6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator*s opinion, would limit the subject*s ability to participate in the clinical investigation or to comply with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (all groups): Freedom from all-cause mortality at five years post-implant. Performance (mitral groups, groups 1 and 2): Freedom from surgical or transcatheter reintervention for mitral regurgitation at five years post-implant. Performance (tricuspid groups, groups 3 to 5): Percent of subjects with at least a one-class improvement in NYHA functional classification at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Freedom from the following events from implant through five years post implant: o All-cause mortality o Cardiac death, as adjudicated by the CEC o Operated valve related mortality, as adjudicated by the CEC o Surgical reoperation on the repaired valve o Transcatheter intervention on the repaired valve o Reoperation or transcatheter intervention for regurgitation in the repaired valve as adjudicated by the CEC o The composite event of operated-valve endocarditis or thrombosis, thromboembolism, stroke, major bleeding or annuloplasty device dehiscence o All-cause mortality and the composite event of operated-valve endocarditis or thrombosis, thromboembolism, stroke, major bleeding, or annuloplasty device dehiscence. • NYHA Functional Class at baseline, discharge, and one, three and five years post-implant. • Kidney and liver function lab test panel values at discharge, one, three and five years post-implant in Group 3 and 4 subjects. • Cardiac medication usage at baseline, discharge, one, three and five years post-Implant. • Transthoracic echocardiography (TTE) measurements of repaired valve regurgitation, repaired valve stenosis, ventricular remodeling and ventricular function at baseline, discharge, and one, three and five years post-implant. | — |
Countries
Netherlands
Outcome results
None listed