Clinical trials: Transplant, Heart
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
Heart and Lung Transplant
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2…
- Trial name
- NCT00154193
- Testing
- cyclosporine
- Where
- Switzerland
- Volunteers
- 190 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplant Rejection
Molecular Evidence of Rejection Intervention Trial
MERIT is a double-blind, multi-center, placebo-controlled, randomized clinical trial. Heart transplant recipients with dual-positive GEP/dd-cfDNA assays with a corresponding negative biopsy between 2 months and 2 years…
- Trial name
- MERIT (NCT07905599)
- Testing
- Prednisone
- Volunteers
- 200 people
- Sponsor
- CareDx
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.
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.
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
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
Saphenous Vein Graft Disease, Myocardial Ischemia
Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft
This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.
- Conditions
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Trial name
- NCT01042444
- Testing
- GARDEX™
- Where
- 3 sites in Israel
- Volunteers
- 6 people
- Sponsor
- Gardia Medical
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
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
Life-threatening, Biventricular Heart Failure
SynCardia 70cc TAH-t for Destination Therapy (DT)
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible…
- Conditions
- Life-threatening, Biventricular Heart Failure, Ineligible for Cardiac Transplant
- Trial name
- RA-540 (NCT02232659)
- Testing
- 70cc TAH-t for Destination Therapy
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- SynCardia Systems. LLC
Cardiac Bypass Surgery (CABG)
Collect Flow and Ultrasound Images of Coronary Bypass Grafts
This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).
- Trial name
- CASES (NCT06360224)
- Testing
- MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes
- Volunteers
- 100 people
- Sponsor
- Medistim ASA
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular
Heart Transplant Rejection
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart…
- Trial name
- ProTECT (NCT05205551)
- Where
- United States
- Volunteers
- 411 people
- Sponsor
- Natera, Inc.
Acute Rejection of Cardiac Transplant
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the…
- Trial name
- INNOGRAFTRS001 (NCT04274712)
- Testing
- INNOGRAFT Heart Suite
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- Myway Gentics Srl
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
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
Graft Rejection, Heart Diseases
A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation
This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant patients for acute rejection beginning 2-6…
- Trial name
- EIMAGE (NCT00962377)
- Testing
- Endomyocardial biopsy, AlloMap Molecular Testing
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- XDx
Coronary Artery Disease
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke…
- Trial name
- NCT00088179
- Testing
- pexelizumab in conjunction with CABG
- Where
- 188 sites in United States, France and 2 more
- Volunteers
- 4,000 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cardiovascular Disease
Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery
- Trial name
- NCT00038454
- Testing
- Hemolink (hemoglobin raffimer IV solution)
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 180 people
- Sponsor
- Hemosol