Clinical trial NCT02097420: HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Disease
Damaged Mitral Valve
Malfunctioning Mitral Heart Valve
Mitral Valve Replacement
Keywords: Mitral valve
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 23
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth
timeFrame: 12 months
measure: Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography
timeFrame: 12 months
measure: Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography
timeFrame: 12 months
measure: Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
timeFrame: 12 months
measure: Primary Safety Endpoint: Rate of Total Valve-related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Percentage Change in Height Percentiles From Baseline to 12 Months
timeFrame: 12 months
measure: Percentage Change in Weight Percentiles From Baseline to 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles (USC)
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: University of Missouri-Kansas City School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital / Sanger Heart & Vascular Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
References: