Medtronic HAMMOCK Post Approval Study

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)

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

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Device: Mosaic model 305, model 310, and ultra model 305

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • München, Germany, 80636
    • Deutsches Herzzentrum München Klinik an der TU München
• Poland
  • Warsaw, Poland
    • Institute of Cardiology in Warsaw
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Saint Francis Health
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • Saint Joseph Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Subjects requiring aortic or mitral valve replacement of the native valve.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary cohort; Subjects requiring aortic or mitral valve replacement	Device: Mosaic model 305, model 310, and ultra model 305; Aortic or mitral valve replacement; Other Names: Hancock II model T505, model T510, and ultra model T505

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths, Reinterventions, or Explants	Number of deaths, reinterventions, or explants related to the valve	1-year post implant
Number of Deaths, Reinterventions, or Explants	Number of deaths, reinterventions, or explants related to the valve	3-years post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Gradient (mmHg)	Measured by echocardiogram via Echo Core Lab	1-year post implant
Peak Gradient (mmHg)	Measured by echocardiogram via Echo Core Lab	1-year post implant
Effective Orifice Area (EOA)	Measured by echocardiogram via Echo Core Lab	1-year post implant
Effective Orifice Area Index (EOAi)	EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area	1-year post implant
Cardiac Output	Measured by echocardiogram via Echo Core Lab	1-year post implant
Cardiac Index	Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area	1-year post implant
Performance Index	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.	1-year post implant
Transvalvular Regurgitation	Measured by echocardiogram via Echo Core Lab	1-year post implant
Paravalvular Regurgitation	Measured by echocardiogram via Echo Core Lab	1-year post implant
Total Regurgitation	Measured by echocardiogram via Echo Core Lab	1-year post implant
New York Heart Association (NYHA) Classification	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.	1-year post implant
Mean Gradient	Measured by echocardiogram via Echo Core Lab	3-years post implant
Peak Gradient	Measured by echocardiogram via Echo Core Lab	3-years post implant
Effective Orifice Area (EOA)	Measured by echocardiogram via Echo Core Lab	3-years post implant
Effective Orifice Area Index (EOAi)	EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area	3-years post implant
Cardiac Output	Measure by echocardiogram via Echo Core Lab	3-years post implant
Cardiac Index	Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area	3-years post implant
Performance Index	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.	3-years post implant
Transvalvular Regurgitation	Measured by echocardiogram via Echo Core Lab	3-years post implant
Paravalvular Regurgitation	Measured by echocardiogram via Echo Core Lab	3-years post implant
Total Regurgitation	Measured by echocardiogram via Echo Core Lab	3-years post implant
New York Heart Association (NYHA) Classification	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.	3-years post implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 1024882DOC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes