Clinical trials: Heart Transplant
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
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Tricuspid Regurgitation
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled.
- Trial name
- NCT04289870
- Testing
- Trillium™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Innoventric 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.
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
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
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.
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
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
Atrial Fibrillation
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.
- Trial name
- NCT00562432
- Testing
- Plexisyl-AF, No Treatment
- Where
- 3 sites in Germany
- Volunteers
- 32 people
- Sponsor
- LoneStar Heart, Inc.
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
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
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
Advanced Heart Failure, Ischemic Heart Failure
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing…
- Trial name
- NCT07646210
- Testing
- HiCM-188 Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HELP Therapeutics Co., Ltd.
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 Transplant
International EXPAND Heart Pivotal Trial
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve…
- Trial name
- EXPANDHeart (NCT02323321)
- Testing
- Preservation of Hearts for Transplantation
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- TransMedics
Coronary Artery Disease
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary…
- Trial name
- OPC (NCT02698852)
- Testing
- BuMA Supreme
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Coronary Artery Bypass Surgery
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during…
- Trial name
- NCT00858936
- Testing
- IK-1001, Normal Saline
- Where
- 8 sites in Australia, Canada
- Volunteers
- 6 people
- Sponsor
- Mallinckrodt
Coronary Artery Disease (CAD)
Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG
This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo.
- Trial name
- EXACT-CABG (NCT07118449)
- Testing
- XC001
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- XyloCor Therapeutics, 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