HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm.

20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Valve Disease; Damaged Mitral Valve; Malfunctioning Mitral Heart Valve; Mitral Valve Replacement
• Intervention / Treatment: Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Detailed Description

The study is a single arm, prospective, non-randomized, multi-center clinical investigation.

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles (USC)
    • Sacramento, California, United States, 95817
      • University of California - Davis Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital of Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital of Chicago
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 62108
      • University of Missouri-Kansas City School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Children's Hospital & Medical Center
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital/Columbia University
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Levine Children's Hospital / Sanger Heart & Vascular Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Spokane, Washington, United States, 99204
      • Sacred Heart Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No

Description

IDE Cohort -

Inclusion Criteria:

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 other than those noted in the exclusion criteria.

Exclusion Criteria:

1. 1. Subject is > 5 years of age.
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-

Prospective Inclusion Criteria:

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.

Prospective Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single device arm; Mitral valve replacement	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth	The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.	12 months
Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography	Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months
Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography	Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation	Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months
Primary Safety Endpoint: Rate of Total Valve-related Adverse Events	Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Height Percentiles From Baseline to 12 Months	Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit.	12 months
Percentage Change in Weight Percentiles From Baseline to 12 Months	Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Orifice Area (EOA) as Assessed by Echocardiography	Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. EOA is assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months
EOA Index as Assessed by Echocardiography	EOA index is calculated as the subject's effective orifice area divided by subject's body surface area. EOA index as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months
Performance Index as Assessed by Echocardiography	Performance index is calculated as the subject's effective orifice area divided by the subject's pre-implant interval orifice area. Performance index as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Vinny Podichetty, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimated): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mitral valve
• Other Study ID Numbers: CL06404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO