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

NCT02097420 | Completed Results DMC

• 1 other identifier: CL06404
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Mitral Valve Disease; Damaged Mitral Valve; Malfunctioning Mitral Heart Valve; Mitral Valve Replacement

Keywords

Mitral valve

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Percentage Change in Height Percentiles From Baseline to 12 Months

  12 months

• Percentage Change in Weight Percentiles From Baseline to 12 Months

  12 months

Study Arms (1)

Single device arm

OTHER

Mitral valve replacement

Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Interventions

Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve DEVICE

Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions

Single device arm

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject requires mitral valve replacement.\*
• Subject's legally authorized representative gives written consent to participate in the clinical study.
• Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.

You may not qualify if:

• \. Subject is \> 5 years of age.
• Subject has a contraindication to anticoagulant/antiplatelet medication.
• Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.\*
• Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve.
• Subject has active endocarditis.
• Subject has active myocarditis.
• Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure.
• Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure.
• Subject has a non-cardiac illness resulting in a life expectancy of \< 1 year.
• Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure.
• Subject has been previously enrolled and implanted in this study.
• Subject is participating in another study for an investigational drug and/or device.
• 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-

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Los Angeles (USC)

Los Angeles, California, 90027, United States

Location

University of California - Davis Medical Center

Sacramento, California, 95817, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

University of Missouri-Kansas City School of Medicine

Kansas City, Missouri, 62108, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, 68198, United States

Location

New York Presbyterian Hospital/Columbia University

New York, New York, 10032, United States

Location

Levine Children's Hospital / Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Results Point of Contact

• Title: Vinny Podichetty, Clinical Program Director
• Organization: Abbott

vinny.podichetty@abbott.com

+1 779-209-9425

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: May 7, 2015
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2023
• Last Updated: February 11, 2025
• Results First Posted: June 2, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)