Clinical trials: Cardiac Transplant Disorder
Coronary Artery Disease, Myocardial Ischemia
The eSVS® Mesh Randomized Post-Market Study
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01462721
- Testing
- eSVS® Mesh
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Kips Bay Medical, Inc.
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Chronic Total Occlusion of Coronary Artery
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional…
- Trial name
- NCT01978860
- Testing
- NovaCross, CTO
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- Chanan Schneider
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
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
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
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
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.
Atrial Fibrillation, Atrial Flutter
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
- Trial name
- NCT00125320
- Testing
- RSD1235
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Inc
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
Mild Cognitive Impairment
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
The primary objective is to compare mild cognitive impairment in the AL-208 group with the placebo group at 14 + - 3 days after CABG surgery
- Trial name
- NCT00404014
- Testing
- AL-208
- Where
- 28 sites in United States, Canada
- Volunteers
- 234 people
- Sponsor
- Allon Therapeutics
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.
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH