Valve Transplant for Heart Valve Disease
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Allogeneic Valve Transplantation for heart valve disease?
The research indicates that allogeneic valve transplantation is an emerging therapy using living valves from donor hearts, with studies exploring its potential use and challenges, such as immune response and contamination risks. While there is evidence of its use in conditions like endocarditis, the effectiveness data for heart valve disease specifically is limited.
12345Is valve transplantation generally safe for humans?
Valve transplantation, such as allogeneic valve transplantation, has some safety concerns. There is a rare risk of fungal infection from contaminated valves, which can be serious and sometimes fatal. Additionally, immune system reactions can lead to valve failure, especially in children.
12567How is the treatment Allogeneic Valve Transplantation different from other treatments for heart valve disease?
Allogeneic Valve Transplantation is unique because it uses living valves from donor hearts, which can be more durable and self-repairing compared to mechanical or bioprosthetic valves. This treatment also allows patients to avoid the need for lifelong blood-thinning medication, making it particularly beneficial for those who cannot take such medication, like women who wish to become pregnant or people with bleeding disorders.
16789Eligibility Criteria
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.Inclusion Criteria
I need a heart valve replacement.
I have limited options for valve replacement.
My blood type matches the donor's.
Exclusion Criteria
I have had endocarditis before.
My condition is worsening and expected to shorten my life.
I am less than 30 days old.
I do not have severe kidney or liver failure.
My organs are failing and a transplant wouldn't likely save me.
My BMI is over 35.
I have diabetes with complications affecting organs.
I do not have severe genetic, brain, or syndrome-related abnormalities.
I have a condition that weakens my immune system.
I currently have an infection.
I have HIV or chronic hepatitis B or C.
I had cancer within the last 5 years before a planned transplant.
I had a severe stroke with a high risk of bleeding in the brain.
I have received a heart transplant.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Valve transplantation groupExperimental Treatment1 Intervention
This arm undergoes Allogeneic Valve transplantation
Allogeneic Valve Transplantation is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Allogeneic Valve Transplantation for:
- Congenital valve disease
- Infective endocarditis
- Small aortic roots
- Fertile women contemplating pregnancy
🇺🇸 Approved in United States as Allogeneic Valve Transplantation for:
- Severe heart failure
- Severe valve dysfunction
- Prosthetic valve infection
- Invasion beyond the valve leaflets
- Recurrent systemic embolization
- Large mobile vegetations
- Persistent sepsis despite adequate antibiotic therapy
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
Loading ...
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
References
Trends in pediatric donor heart discard rates and the potential use of unallocated hearts for allogeneic valve transplantation. [2023]Allogeneic valve transplantation is an emerging therapy that delivers a living valve from a donor heart. We reviewed the national discard rate of pediatric and young adult (aged 25 years or younger) donor grafts to estimate the number of hearts potentially available to source valve allotransplantation.
Candida albicans endocarditis associated with a contaminated aortic valve allograft--California, 1996. [2008]An allograft heart valve is an implanted valve obtained from a person not related to the recipient. Fungal endocarditis secondary to extrinsic valve contamination is a rare but potentially fatal complication of allograft valve replacement; its incidence following surgery for heart valve replacement with allografts is approximately 0.3%. Treatment often is unsuccessful, and death is a frequent outcome. This report describes the investigation of a case of Candida albicans endocarditis associated with a contaminated aortic valve allograft. The findings indicated that antimicrobial processing of the initial aortic valve allograft did not eliminate C. albicans from the tissue.
The allograft valve in heart transplantation and valve replacement. Genetic assessment of the origin of the cells by means of deoxyribonucleic acid profiles. [2006]Assessment of the cellular origin of allograft valves is essential in comprehending their biologic behavior and in improving preparation methods. In this study we retrospectively analyzed 10 allografts obtained from patients who underwent valve replacement or heart transplantation. Histologic evaluation and deoxyribonucleic acid amplification by polymerase chain reaction technology with fluorescence labeled primers was performed on different parts of the valve leaflets. Automated analyses of the obtained amplimers showed in the heart transplantation group the presence of receptor cells interspersed with native donor cells in three cases. Preliminary results for the valve replacement group are inconclusive as yet.
Prevention of allograft heart valve failure in a rat model. [2013]Allograft heart valves are commonly used in cardiac surgery. Despite mounting evidence that these valves are immunogenic, leading to premature failure, current clinical practice does not attempt to minimize or control such a response. The objective of this study was to evaluate immune modulatory approaches to ameliorate allograft valve failure in a rat model.
Allograft replacement of the aortic valve for active endocarditis. [2016]In the 50 months preceding March 1995, 35 adult patients underwent aortic valve replacement with a cryopreserved human aortic valve allograft. Nine of these patients had active endocarditis. The remaining 26 patients had aortic valve pathology without active infection. This study consists of a comparison of these two groups.
Partial Heart Transplantation in Adult Cardiac Surgery. [2023]Many young adults require heart valve replacements. Current options for valve replacement in adults include mechanical valves, bioprosthetic valves, or the Ross procedure. Of these, mechanical and bioprosthetic valves are the most common options, although mechanical valve usage predominates in younger adults due to durability, while bioprosthetic valve usage predominates in older adults. Partial heart transplantation is a new method of valvular replacement that can deliver durable and self-repairing valves and allow adult patients freedom from anticoagulation therapy. This procedure involves transplantation of donor heart valves only, permitting expanded utilization of donor hearts as compared with orthotopic heart transplantation. In this review, we discuss the potential benefits of this procedure in adults who elect against the anticoagulation regimen required of mechanical valve replacements, although it has not yet been clinically established. Partial heart transplantation is a promising new therapy for the treatment of pediatric valvular dysfunction. This is a novel technique in the adult population with potential utility for valve replacement in young patients for whom anticoagulation therapy is problematic, such as women who wish to become pregnant, patients with bleeding disorders, and patients with active lifestyles.
T lymphocytes mediate leaflet destruction and allograft aortic valve failure in rats. [2019]Allograft heart valves are commonly used in cardiac surgery but ultimately fail. This situation is most acute in children. This study addresses the role of T cell-mediated immune damage in allograft valve failure.
Monocusp aortic valve replacement in dogs: an experimental model. [2019]Aortic valve replacement using human allograft valves is a well established procedure, following which histological evidence of a host-graft interaction is seen. This varies in intensity, depending on the types of sterilizing and storage agents to which the allograft is exposed prior to insertion. A canine experimental model which enables study of these tissue ingrowth patterns in variously treated allografts has been devised. The technique is described in detail.
What tissue bankers should know about the use of allograft heart valves. [2016]Heart valve allografts (usually referred to as 'homografts') have been used in cardiac surgery for over 45 years when they were amongst the first valves ever used. Today they remain an important part of valve replacement and reconstructive surgery, particularly in the field of congenital heart disease. There are currently seven tissue banks on the UK and Eire that procure, prepare and store these homografts for surgical implantation, currently providing around 700 grafts per year. This article reviews the history and applications of homografts and compares their performance and outcomes with current prosthetic alternatives. It also describes the processes of valve procurement and storage and describes their clinical applications, hopefully providing tissue bankers with the surgeon's insight into what is required. Homograft degeneration and the natural history of these tissues is discussed, together with future expectations and developments in homograft valve technology.