Clinical trials: Heart Transplantation
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Heart Failure
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent…
- Trial name
- BeneMACs (NCT00983190)
- Testing
- Left Ventricular Assist Device (HeartMate II)
- Where
- 2 sites in Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
- Trial name
- NCT02645539
- Testing
- intravascular ventricular assist system (iVAS)
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- NuPulseCV
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Graft Rejection
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
- Trial name
- NCT00300274
- Testing
- everolimus, mycophenolate mofetil, cyclosporine
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 721 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.
- Trial name
- NCT00591799
- Testing
- The Jarvik 2000 Ventricular Assist System
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Jarvik Heart, Inc.
Heart Transplant
US National OCS Heart Perfusion (OHP) Registry
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
- Trial name
- NCT05915299
- Testing
- OCS Heart
- Where
- 37 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
Heart Transplantation
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in…
- Trial name
- NCT00170859
- Testing
- Everolimus
- Where
- Germany
- Sponsor
- Novartis Pharmaceuticals
Complete DiGeorge Anomaly, DiGeorge Syndrome
Thymus Transplantation Safety-Efficacy
Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection.
- Conditions
- Complete DiGeorge Anomaly, DiGeorge Syndrome, DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- NCT01220531
- Testing
- Cultured Thymus Tissue
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Cytomegalovirus Infections, Heart Transplantation
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- Trial name
- NCT01165580
- Testing
- valganciclovir [Valcyte]
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Heart Failure, Right-Sided, Cardiac Failure
Syncardia 50cc TAH-t as a Bridge to Transplant
The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support…
- Conditions
- Heart Failure, Right-Sided, Cardiac Failure, Heart Failure, Left-Sided
- Trial name
- NCT02459054
- Testing
- SynCardia 50cc temporary Total Artificial Heart (TAH-t)
- Where
- 26 sites in United States
- Volunteers
- 16 people
- Sponsor
- SynCardia Systems. LLC
Heart Transplantation
Non-ischemic Preservation of the Donor Heart in Heart Transplantation
The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial.
- Trial name
- NCT03991923
- Testing
- XVIVO heart preservation devices, Standard ICSS
- Where
- 15 sites in Austria, Belgium and 6 more
- Volunteers
- 230 people
- Sponsor
- XVIVO Perfusion
Heart Transplantation
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy.
- Trial name
- NCT00098007
- Testing
- Everolimus (Certican)
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
- Trial name
- NCT00483197
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 29 sites in United States
- Volunteers
- 140 people
- Sponsor
- Ventracor
Congestive Heart Failure, Cardiac Transplantation
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide).
- Conditions
- Congestive Heart Failure, Cardiac Transplantation, Renal Insufficiency, Renal Failure
- Trial name
- NCT00338455
- Testing
- Natrecor (nesiritide)+Standard Care+dobutamine or milrinone
- Where
- 14 sites in United States
- Volunteers
- 16 people
- Sponsor
- Scios, Inc.
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Non-Melanoma Skin Carcinoma
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g
The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung…
- Trial name
- NCT01480219
- Testing
- voriconazole (Vfend), no voriconazole (Vfend)
- Volunteers
- 467 people
- Sponsor
- Pfizer
Transplant
OCS Heart Perfusion Post-Approval Registry
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
- Trial name
- NCT05047068
- Testing
- OCS Heart System
- Where
- 27 sites in United States
- Volunteers
- 350 people
- Sponsor
- TransMedics
Advanced Heart Failure
Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure
The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.
- Trial name
- EFICAS (NCT04475393)
- Testing
- Carmat Total Artificial Heart, Standard therapy for heart failure
- Where
- 10 sites in France
- Volunteers
- 104 people
- Sponsor
- Carmat SAS
Renal Function and Chronic Allograft Vasculopathy
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down…
- Trial name
- SCHEDULE (NCT01266148)
- Testing
- Cyclosporine, Mycophenolate mofetil, Corticosteroids
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 115 people
- Sponsor
- Novartis Pharmaceuticals