Clinical trials: Heart Transplant
Ventricular Dysfunction, Myocardial Infarction
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle…
- Trial name
- TABMMI (NCT00507468)
- Testing
- Transendocaridal Transplantation of Autologous Bone Marrow
- Where
- 2 sites in Argentina
- Volunteers
- 20 people
- Sponsor
- BioCardia, Inc.
Heart Transplant, Heart Failure
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts…
- Conditions
- Heart Transplant, Heart Failure, Transplant; Failure, Heart
- Trial name
- NIHP-CAP-001 (NCT06895070)
- Testing
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- XVIVO Perfusion
Heart Disease
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed…
- Trial name
- NCT01478061
- Testing
- Anastomosis (C-Port® )
- Where
- 7 sites in United States
- Volunteers
- 115 people
- Sponsor
- Cardica, Inc
Heart Failure
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
- Trial name
- NCT02869022
- Testing
- Custodiol-N, Custodiol, organ perfusion for heart transplantation
- Where
- 9 sites in Austria, Germany
- Volunteers
- 105 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
Left Ventricular Dysfunction, Acute Myocardial Infarction
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
- Trial name
- NCT03902067
- Testing
- UC-MSC, Control Group
- Where
- China
- Sponsor
- Shanghai Life Science & Technology
Ischemic Heart Failure, Ischemic Heart Disease
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
- Conditions
- Ischemic Heart Failure, Ischemic Heart Disease, Ischemic Cardiomyopathy
- Trial name
- NCT00102128
- Testing
- Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
- Where
- 28 sites in Belgium, France and 4 more
- Sponsor
- Genzyme, a Sanofi Company
Cardiac Transplantation
Everolimus in de Novo Heart Transplant Recipients
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute…
- Trial name
- EVERHEART (NCT01017029)
- Testing
- Everolimus, Mycophenolate mofetil + Everolimus
- Where
- 12 sites in Italy
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
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
Cardiovascular Disease, Coronary Artery Bypass
Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked.
- Trial name
- NCT00451256
- Testing
- AVI-5126
- Where
- Ukraine
- Volunteers
- 600 people
- Sponsor
- Sarepta Therapeutics, Inc.
Sudden Cardiac Death, Ventricular Fibrillation
LifeVest Post-CABG Registry
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease…
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction
- Trial name
- NCT01448005
- Testing
- wearable defibrillator (LifeVest)
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Zoll Medical Corporation
Blood Loss, Surgical
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the…
- Trial name
- NCT00448864
- Testing
- Ecallantide
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
DiGeorge Anomaly, DiGeorge Syndrome
Thymus Transplantation Dose in DiGeorge #932
One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome.
- Conditions
- DiGeorge Anomaly, DiGeorge Syndrome, Complete DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- NCT00576836
- Testing
- Cultured Thymus Tissue Implantation (CTTI), Cultured Thymus Tissue Implantation with Parathyroid Transplantation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Delayed Graft Function
Study on Delayed Graft Function Using Paired Kidneys
The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.
- Trial name
- NCT01561599
- Testing
- BB3, Normal Saline
- Where
- 3 sites in Netherlands, Spain and 1 more
- Volunteers
- 12 people
- Sponsor
- Angion Biomedica Corp
Coronary Artery Disease, General Anesthetic Drug Allergy
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies.
- Conditions
- Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
- Trial name
- NCT01294163
- Testing
- Xenon, Sevoflurane, Propofol
- Where
- 17 sites in France, Germany and 2 more
- Volunteers
- 509 people
- Sponsor
- Air Liquide Santé International
Saphenous Vein Graft Disease, Myocardial Ischemia
The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts
This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) intervention.
- Conditions
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Trial name
- RETRIEVE (NCT00453518)
- Testing
- FiberNet EPS used during SVG intervention.
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Lumen Biomedical
Coronary Artery Bypass Surgery
CD0104 VEST II Post Marketing Surveillance Study
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
- Trial name
- VEST II (NCT02332330)
- Testing
- VEST
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.
Coronary Artery Disease
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass…
- Trial name
- NCT00042081
- Testing
- CGT003 (E2F Duplex Decoy)
- Where
- 154 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Anesiva, Inc.
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.
Non-anaemic Patients Undergoing Cardiac Surgery
A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
- Trial name
- CABG-01 (NCT01563367)
- Testing
- Iron isomaltoside 1000 (Monofer®), Natriumklorid 9 mg/ml, Fresenius Kabi
- Where
- Denmark
- Volunteers
- 74 people
- Sponsor
- Pharmacosmos A/S