Medtronic HAMMOCK Post Approval Study

Completed

Conditions: Heart Valve Diseases

Interventions: Device: Mosaic model 305, model 310, and ultra model 305

Registration Number: NCT03139721

Lead Sponsor: Medtronic Cardiac Surgery

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 122

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary cohort	Mosaic model 305, model 310, and ultra model 305	Subjects requiring aortic or mitral valve replacement

Primary Outcome Measures

Name	Time	Method
Number of Deaths, Reinterventions, or Explants	3-years post implant	Number of deaths, reinterventions, or explants related to the valve

Secondary Outcome Measures

Name	Time	Method
Peak Gradient	3-years post implant	Measured by echocardiogram via Echo Core Lab
Cardiac Index	3-years post implant	Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
Performance Index	3-years post implant	The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.
Paravalvular Regurgitation	3-years post implant	Measured by echocardiogram via Echo Core Lab
Mean Gradient (mmHg)	1-year post implant	Measured by echocardiogram via Echo Core Lab
Effective Orifice Area Index (EOAi)	3-years post implant	EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Cardiac Output	3-years post implant	Measure by echocardiogram via Echo Core Lab
Effective Orifice Area (EOA)	3-years post implant	Measured by echocardiogram via Echo Core Lab
New York Heart Association (NYHA) Classification	3-years post implant	Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Peak Gradient (mmHg)	1-year post implant	Measured by echocardiogram via Echo Core Lab
Transvalvular Regurgitation	3-years post implant	Measured by echocardiogram via Echo Core Lab
Total Regurgitation	3-years post implant	Measured by echocardiogram via Echo Core Lab
Mean Gradient	3-years post implant	Measured by echocardiogram via Echo Core Lab

Trial Locations

Locations (7): Saint Joseph Medical Center
🇺🇸
Tacoma, Washington, United States
ProMedica Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Bellin Memorial Hospital
🇺🇸
Green Bay, Wisconsin, United States
Universitätsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, Germany
Deutsches Herzzentrum München Klinik an der TU München
🇩🇪
München, Germany
Institute of Cardiology in Warsaw
🇵🇱
Warsaw, Poland
Franciscan Saint Francis Health
🇺🇸
Indianapolis, Indiana, United States