Clinical trials: Cardiac Transplant
Ventricular Dysfunction, Ventricular Dysfunction, Left
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric.
- Conditions
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- Trial name
- NCT03701997
- Testing
- EXCOR Pediatric
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Berlin Heart, Inc
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
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
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
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
The eMESH 1 Feasibility Study
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc.
- Trial name
- eMESH 1 (NCT01676376)
- Testing
- eSVS Mesh treated saphenous vein graft, Control saphenous vein graft
- Where
- 15 sites in United States, Czechia and 5 more
- Volunteers
- 120 people
- Sponsor
- Kips Bay Medical, Inc.
Congestive Heart Failure
Feasibility Study of BMAC Enhanced CABG
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium
- Trial name
- NCT01074099
- Testing
- BMAC, CABG only
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Harvest Technologies
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Coronary Heart Disease, Multi Vessel Coronary Artery Disease
Optilene® Suture for Coronary Artery Bypass Graft Surgery
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
- Trial name
- OPTICABG (NCT02546557)
- Testing
- Coronary Artery Bypass Graft surgery
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 245 people
- Sponsor
- Aesculap AG
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
Heart Transplant Rejection
Surveillance HeartCare® Outcomes Registry
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
- Trial name
- SHORE (NCT03695601)
- Testing
- Standard of Care
- Where
- 67 sites in United States
- Volunteers
- 2,743 people
- Sponsor
- CareDx
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Coronary Artery Disease, Coronary Arteriosclerosis
Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium.
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Atherosclerosis, Coronary Disease
- Trial name
- NCT00548613
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- TCA Cellular Therapy
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
Low Cardiac Output
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach…
- Trial name
- NCT00529711
- Testing
- Hypertonic lactate, Ringer's lactate
- Where
- Indonesia
- Volunteers
- 66 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Heart Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
- Trial name
- NCT00574743
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- 9 sites in United States, Argentina and 2 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function.
- Trial name
- NCT00364598
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Theregen, Inc.
Heart Failure
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).
- Trial name
- COMPETENCE (NCT01187368)
- Testing
- EVAHEART Left Ventricular Assist System (LVAS), HeartMate 3
- Where
- 12 sites in United States
- Volunteers
- 399 people
- Sponsor
- Evaheart, Inc.
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
Ischemic Heart Disease
Autologous Cell Therapy for Ischemic Heart Failure
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by…
- Trial name
- NCT01353690
- Testing
- AMDC
- Where
- 2 sites in Canada
- Volunteers
- 9 people
- Sponsor
- Cook MyoSite