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

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ClinicalTrials.gov Identifier: NCT02097420
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Disease Damaged Mitral Valve Malfunctioning Mitral Heart Valve Mitral Valve Replacement Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Study Start Date : July 2014
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Valve-related Adverse Events [ Time Frame: 365 days post implant ]
    The actuarial (Kaplan-Meier) rate of total valve-related adverse events experienced through 365 days post implant or until the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.

  2. Survival [ Time Frame: 12 months post implant ]
    Survival at 12 months post implant or survival until the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.

  3. Peak Gradient [ Time Frame: 12 months post implant ]
    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.

  4. Mean Gradient [ Time Frame: 12 months post implant ]
    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.

  5. Valvular Regurgitation [ Time Frame: 12 months post implant ]
    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.


Secondary Outcome Measures :
  1. Height Percentile Ranking [ Time Frame: 12 months post implant ]
    Increase in percentile ranking on the CDC growth chart for height at 12 months post implant or until the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first, compared to baseline.

  2. Weight Percentile Ranking [ Time Frame: 12 months post implant ]
    Increase in percentile ranking on the CDC growth chart for weight at 12 months post implant or until the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first, compared to baseline.

  3. EOA (effective orifice area) [ Time Frame: 12 months post implant ]
    Effective orifice area (EOA) 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.

  4. EOA (effective orifice area) Index [ Time Frame: 12 months post implant ]
    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.

  5. Performance Index [ Time Frame: 12 months post implant ]
    Performance index as assessed by electrocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of subject, whichever comes first.



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject requires mitral valve replacement.*

    *Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion 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.

Exclusion Criteria:

  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.*

    *Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study.

  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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097420


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Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02097420     History of Changes
Other Study ID Numbers: CL06404
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
Mitral valve