Mitral Valve DiseaseNCT02097420
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
A study testing Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in people with Mitral Valve Disease and Damaged Mitral Valve, run by Abbott Medical Devices at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve
- What is being tested?
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 24 sitesUnited States
- Study dates
- 7 May 2015to Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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-
- Prospective 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.
- Prospective Exclusion Criteria:
- Subject is > 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital of Colorado
Aurora, Colorado, 80045
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Levine Children's Hospital / Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Texas Children's Hospital
Houston, Texas, 77030
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, 62108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital Los Angeles (USC)
Los Angeles, California, 90027
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
West Virginia University Hospital
Morgantown, West Virginia, 26506
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York Presbyterian Hospital/Columbia University
New York, New York, 10032
Children's Hospital & Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
University of California - Davis Medical Center
Sacramento, California, 95817
University of Utah Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Being tested
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Keywords
- Mitral valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart ValveDevice
Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
| Study group | Role | What they receive |
|---|---|---|
| Single device arm | Other | Mitral valve replacement Receives: Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study start7 May 2015
- Primary completionMar 2019
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097420
- Sponsor's protocol ID
- CL06404
- Status last verified
- Feb 2025
- First submitted
- 24 Mar 2014
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- ClinicalTrials.gov ID
- NCT02097420
- Acronym / sponsor ID
- CL06404
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Keywords
- Mitral valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 7 May 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single device arm | Other | Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart ValveMitral valve replacement |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart ValveImplantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions | Device | Single device arm |
Primary outcome
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth
Time frame: 12 months
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.
Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography
Time frame: 12 months
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.
Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography
Time frame: 12 months
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.
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Time frame: 12 months
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.
Primary Safety Endpoint: Rate of Total Valve-related Adverse Events
Time frame: 12 months
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.
2 secondary outcomes
Percentage Change in Height Percentiles From Baseline to 12 Months
Time frame: 12 months
Percentage Change in Weight Percentiles From Baseline to 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Disease
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in people with Mitral Valve Disease and Damaged Mitral Valve, run by Abbott Medical Devices at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.