Clinical trial NCT03139721: Medtronic HAMMOCK Post Approval Study
Official title: Medtronic Hancock II® and Mosaic Mitral and Aortic Valves: A Study to Observe the Effects of the Stent Material Change to PEEK Post Approval Study (HAMMOCK PAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects requiring aortic or mitral valve replacement of the native valve.

Brief summary: This study is being conducted to satisfy the post-CE approval requirement.


Eligibility criteria: Inclusion Criteria:

1. Subjects who require aortic or mitral valve replacement of their native valve.
2. Subject is geographically stable and willing to return to the implanting site for all follow-up visits.
3. Subject is of legal age to provide informed consent in the country where they enroll in the study.
4. 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:

1. Subject requires concomitant replacement of the aortic and mitral valves.
2. Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve.
3. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.

Primary outcomes:
measure: Number of Deaths, Reinterventions, or Explants
timeFrame: 1-year post implant
measure: Number of Deaths, Reinterventions, or Explants
timeFrame: 3-years post implant
Secondary outcomes:
measure: Mean Gradient (mmHg)
timeFrame: 1-year post implant
measure: Peak Gradient (mmHg)
timeFrame: 1-year post implant
measure: Effective Orifice Area (EOA)
timeFrame: 1-year post implant
measure: Effective Orifice Area Index (EOAi)
timeFrame: 1-year post implant
measure: Cardiac Output
timeFrame: 1-year post implant
measure: Cardiac Index
timeFrame: 1-year post implant
measure: Performance Index
timeFrame: 1-year post implant
measure: Transvalvular Regurgitation
timeFrame: 1-year post implant
measure: Paravalvular Regurgitation
timeFrame: 1-year post implant
measure: Total Regurgitation
timeFrame: 1-year post implant
measure: New York Heart Association (NYHA) Classification
timeFrame: 1-year post implant
measure: Mean Gradient
timeFrame: 3-years post implant
measure: Peak Gradient
timeFrame: 3-years post implant
measure: Effective Orifice Area (EOA)
timeFrame: 3-years post implant
measure: Effective Orifice Area Index (EOAi)
timeFrame: 3-years post implant
measure: Cardiac Output
timeFrame: 3-years post implant
measure: Cardiac Index
timeFrame: 3-years post implant
measure: Performance Index
timeFrame: 3-years post implant
measure: Transvalvular Regurgitation
timeFrame: 3-years post implant
measure: Paravalvular Regurgitation
timeFrame: 3-years post implant
measure: Total Regurgitation
timeFrame: 3-years post implant
measure: New York Heart Association (NYHA) Classification
timeFrame: 3-years post implant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Franciscan Saint Francis Health
state: Indiana
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Tacoma
country: United States
facility: Saint Joseph Medical Center
state: Washington
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: Deutsches Herzzentrum München Klinik an der TU München
city: Warsaw
country: Poland
facility: Institute of Cardiology in Warsaw
Study officials:
References: