HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
NCT ID: NCT02097420
Last Updated: 2025-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2015-05-07
2023-07-31
Brief Summary
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20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.
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Detailed Description
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The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single device arm
Mitral valve replacement
Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
Interventions
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Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
Eligibility Criteria
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Inclusion Criteria
2. Subject's legally authorized representative gives written consent to participate in the clinical study.
3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.
1. Subject requires mitral valve replacement.\*
2. Subject's legally authorized representative gives written consent to participate in the clinical study.
3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.
* Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study.
Exclusion Criteria
2. Subject has a contraindication to anticoagulant/antiplatelet medication.
3. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.\*
4. Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve.
5. Subject has active endocarditis.
6. Subject has active myocarditis.
7. Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure.
8. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure.
9. Subject has a non-cardiac illness resulting in a life expectancy of \< 1 year.
10. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure.
11. Subject has been previously enrolled and implanted in this study.
12. Subject is participating in another study for an investigational drug and/or device.
13. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results.
* Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study.
Continued Access Cohort-
1. Subject is \> 5 years of age.
2. Subject has a contraindication to anticoagulant/antiplatelet medication.
Retrospective Eligibility Criteria:
1. The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV.
2. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy.
3. The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable).
4. Either
1. the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward.
OR
2. the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted.
5 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles (USC)
Los Angeles, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
New York Presbyterian Hospital/Columbia University
New York, New York, United States
Levine Children's Hospital / Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CL06404
Identifier Type: -
Identifier Source: org_study_id
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