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Procedure

Valve Transplant for Heart Valve Disease

N/A
Recruiting
Led By Sitaram Emani, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients requiring aortic or pulmonary valve replacement
Insufficient options available for valve replacement
Must not have
History of endocarditis
Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

"This trial involves taking heart valves from organ donors and putting them into patients who need a new heart valve."

Who is the study for?
This trial is for patients with various heart valve diseases who require a new heart valve. Participants should need an aortic valve replacement and be suitable candidates for receiving valves from organ donors.Check my eligibility
What is being tested?
The study involves transplanting heart valves obtained from organ donors into patients with defective or diseased aortic valves, to see if this can effectively treat their condition.See study design
What are the potential side effects?
Potential side effects may include infection risks at the surgery site, rejection of the donor valve by the patient's body, blood clots, bleeding complications, and irregular heart rhythms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a heart valve replacement.
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I have limited options for valve replacement.
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My blood type matches the donor's.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had endocarditis before.
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My condition is worsening and expected to shorten my life.
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I am less than 30 days old.
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I do not have severe kidney or liver failure.
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My organs are failing and a transplant wouldn't likely save me.
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My BMI is over 35.
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I have diabetes with complications affecting organs.
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I do not have severe genetic, brain, or syndrome-related abnormalities.
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I have a condition that weakens my immune system.
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I currently have an infection.
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I have HIV or chronic hepatitis B or C.
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I had cancer within the last 5 years before a planned transplant.
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I had a severe stroke with a high risk of bleeding in the brain.
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I have received a heart transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Leaflet Growth
Valve Annulus Growth
Valve Regurgitation
Secondary outcome measures
Survival
Ventricular Function

Trial Design

1Treatment groups
Experimental Treatment
Group I: Valve transplantation groupExperimental Treatment1 Intervention
This arm undergoes Allogeneic Valve transplantation

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,947 Total Patients Enrolled
Sitaram Emani, MDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
102 Total Patients Enrolled
~3 spots leftby Jun 2027