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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Leaflet Growth

Valve Annulus Growth

Valve Regurgitation

Secondary study objectives

Survival

Ventricular Function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Valve transplantation groupExperimental Treatment1 Intervention

This arm undergoes Allogeneic Valve transplantation

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

782 Previous Clinical Trials

5,581,187 Total Patients Enrolled

Sitaram Emani, MDPrincipal InvestigatorBoston Children's Hospital

2 Previous Clinical Trials

102 Total Patients Enrolled

~3 spots leftby Jun 2027

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