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Procedure

Valve transplantation group for Valvular Heart 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

766 Previous Clinical Trials

5,580,785 Total Patients Enrolled

Sitaram Emani, MDPrincipal InvestigatorBoston Children's Hospital

2 Previous Clinical Trials

102 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for participants in this research study?

"The details on clinicaltrials.gov indicate that this study is presently seeking volunteers. Initially shared on May 1, 2024, the last update was made on April 25, 2024."

Answered by AI

Is this research study enrolling participants older than two decades of age?

"Individuals aged between 30 days and 50 years old are sought for this trial. Notably, there are 89 trials catering to participants under 18 and a further 311 targeting individuals over the age of 65."

Answered by AI

What is the current number of participants enrolled in this research endeavor?

"Indeed, the information on clinicaltrials.gov highlights that this study is presently enrolling participants. The trial was first listed on May 1st, 2024 and underwent its latest update on April 25th, 2024. It aims to recruit a total of four patients from one specific site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic Valve Transplantation

Sitaram Emani 2024. "Allogeneic Valve Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06387446.

All > Paid Studies Boston