N/A
N=23
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Mitral Valve Disease · Damaged Mitral Valve · Malfunctioning Mitral Heart Valve · Mitral Valve Replacement
Bottom Line
View on ClinicalTrials.gov: NCT02097420 ↗Enrolled (actual)
23
Serious AEs
82.6%
Results posted
Jun 2020
Primary outcome: Primary: Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth — 71.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth |
71.0 | — |
| PRIMARY Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography |
19.8 | — |
| PRIMARY Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography |
7.9 | — |
| PRIMARY Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation |
9; 3; 1; 1; 0; 0 | — |
| PRIMARY Primary Safety Endpoint: Rate of Total Valve-related Adverse Events |
64.3 | — |
| SECONDARY Percentage Change in Height Percentiles From Baseline to 12 Months |
59.4 | — |
| SECONDARY Percentage Change in Weight Percentiles From Baseline to 12 Months |
370.8 | — |
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.
Eligibility Criteria
IDE Cohort -
Inclusion Criteria
- 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.
- Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria.
Exclusion Criteria
- 1. 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 5 years of age.
- Subject has a contraindication to anticoagulant/antiplatelet medication.
Retrospective Eligibility Criteria:
- The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV.
- An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy.
- 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).
- Either
- 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
- the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted.
Data sourced from ClinicalTrials.gov (NCT02097420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.