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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 below
Select...
I have had a Ross procedure on my pulmonary valve.
Select...
I need a mitral valve replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more
Secondary 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
635 Previous Clinical Trials
405,212 Total Patients Enrolled
Angie RoachStudy DirectorAbbott Medical Devices
1 Previous Clinical Trials
71 Total Patients Enrolled
Kyle BrunnerStudy DirectorAbbott Medical Devices
2 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (Mechanical Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02097420 — N/A
Mitral Valve Replacement Research Study Groups: Single device arm
Mitral Valve Replacement Clinical Trial 2023: SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve Highlights & Side Effects. Trial Name: NCT02097420 — N/A
SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (Mechanical Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02097420 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How prolific is the deployment of this trial throughout the state?

"This clinical trial is conducted across 31 different sites, including those located in Spokane, Los Angeles and New york. For convenience sake, it would behove potential participants to choose the clinic nearest them for minimal travel requirements."

Answered by AI

Is there still availability for patients to join the clinical trial?

"Clinicaltrials.gov states that this trial has closed recruitment, with the original post dating back to May 7th 2015 and last update on October 19th 2022. However, there are 15 other medical studies available for enrollment at present."

Answered by AI
~2 spots leftby Mar 2025