Clinical trials: Heart Transplantation
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, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
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
Heart Diseases, Heart Transplantation
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
- Trial name
- NCT00157014
- Testing
- Tacrolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 13 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment…
- Trial name
- NCT03644485
- Testing
- Tacrolimus immediate-release formulation, Tacrolimus prolonged-release formulation, Induction therapy
- Where
- 14 sites in China
- Volunteers
- 284 people
- Sponsor
- Astellas Pharma China, 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
Heart Failure
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
- Trial name
- NCT00710567
- Testing
- DuraHeart Left Ventricular Assist System (LVAS)
- Where
- 26 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Terumo Heart Inc.
Lung Transplant
CIS001 Extension Study of Cyclosporine Inhalation Solution
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
- Trial name
- CIS002 (NCT00938236)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 16 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- APT Pharmaceuticals, Inc.
Advanced Heart Failure, Heart Transplantation
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy…
- Conditions
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- Trial name
- TORCH-002 (NCT07836803)
- Testing
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
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 Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
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
Heart Transplant Failure and Rejection
Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first…
- Trial name
- DETECT (NCT05081739)
- Testing
- Prospera Transplant Assessment, Endomyocardial biopsy
- Sponsor
- Natera, Inc.
Heart Transplant
OCS DCD Heart + CAP Continued Follow-Up
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.
- Trial name
- NCT05741723
- Testing
- OCS Heart
- Where
- 20 sites in United States
- Volunteers
- 276 people
- Sponsor
- TransMedics
Disorder Related to Cardiac Transplantation
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Trial name
- NOCTET (NCT00377962)
- Testing
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI)
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 282 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplant
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.
- Trial name
- OPTIMIZE-HTx (NCT06942156)
- Testing
- Everolimus, Mycophenolate mofetil Tablet/Capsule
- Where
- South Korea
- Volunteers
- 140 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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
Heart Transplant Rejection
Heartsbreath Test for Heart Transplant Rejection
The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).
- Trial name
- Heartsbreath (NCT01397812)
- Testing
- BreathScanner 1.0, BreathLink
- Where
- 5 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- Menssana Research, Inc.
Heart Transplant
Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation
This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation.
- Trial name
- DEFINE-HT (NCT05309382)
- Testing
- Prospera
- Where
- 9 sites in United States
- Volunteers
- 147 people
- Sponsor
- Natera, Inc.
Heart Transplant
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Trial name
- NCT04615182
- Testing
- Transplant
- Where
- 25 sites in United States
- Volunteers
- 90 people
- Sponsor
- TransMedics