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Mechanical Heart Valve
Mechanical Heart Valve Replacement for Mitral Valve Disease
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study
Subject requires mitral valve replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is meant to show that it is safe and effective to offer a replacement mitral valve for patients whose anatomy is too small for the currently commercially available valves. 23 people were enrolled in total.
Who is the study for?
This trial is for patients needing a mitral valve replacement due to small anatomy unsuitable for standard valves. Participants must have a legal representative's consent, be able to attend follow-ups, and may have other heart procedures if not excluded by the criteria.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve as a mitral valve replacement in patients with limited anatomical space that precludes use of standard-sized valves.See study design
What are the potential side effects?
While specific side effects are not listed, mechanical heart valve replacements generally carry risks such as blood clot formation (requiring lifelong blood-thinning medication), bleeding from anticoagulation therapy, infection, or valve malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a Ross procedure on my pulmonary valve.
Select...
I need a mitral valve replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth
Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
+2 moreSecondary outcome measures
Percentage Change in Height Percentiles From Baseline to 12 Months
Percentage Change in Weight Percentiles From Baseline to 12 Months
Other outcome measures
EOA Index as Assessed by Echocardiography
Effective Orifice Area (EOA) as Assessed by Echocardiography
Performance Index as Assessed by Echocardiography
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single device armExperimental Treatment1 Intervention
Mitral valve replacement
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
640 Previous Clinical Trials
405,797 Total Patients Enrolled
Vinny PodichettyStudy DirectorAbbott
7 Previous Clinical Trials
4,104 Total Patients Enrolled
Angie RoachStudy DirectorAbbott Medical Devices
1 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a Ross procedure on my pulmonary valve.I am older than 5 years.I have an ongoing heart infection.I have a serious illness, not heart-related, limiting my life to under a year.I need a mitral valve replacement.I've had a recent neurological issue that hasn't improved for at least 30 days.My heart condition hasn't stabilized 2 days before the study.I need another heart surgery within a year after this study.I need a heart valve replacement.I can attend all required study visits and follow-ups.I am eligible for the study even if I am having other heart procedures.I cannot take blood thinners due to health reasons.I have active inflammation of the heart muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Single device arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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