Clinical trials: Cardiac Surgical Patients
Atrial Fibrillation
Medical Need of OAC Reversal
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
- Trial name
- NCT03254147
- Testing
- warfarin, dabigatran, Apixaban
- Where
- Japan
- Volunteers
- 53,969 people
- Sponsor
- Boehringer Ingelheim
Cardiac Surgery
Efficacy and Safety of Sodium Heparin in Patients
The objective of this study is verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require…
- Trial name
- NCT00894959
- Testing
- Heparin sodium Blausiegel 1, Heparin sodium APP
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil
Myocardial Ischemia
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
- Trial name
- ATHENA (NCT01556022)
- Testing
- ADRCs processed by the Celution System
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cytori Therapeutics
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Coronary Heart Disease, Graft Occlusion, Vascular
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG)…
- Trial name
- NCT01245634
- Testing
- RO4905417
- Where
- 38 sites in United States, Canada
- Volunteers
- 384 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease, CKD
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who…
- Conditions
- Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
- Trial name
- ARTEMIS (NCT05746559)
- Testing
- Ravulizumab
- Where
- 130 sites in United States, Argentina and 18 more
- Volunteers
- 555 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cardiac Surgery Associated - Acute Kidney Injury
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery
The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.
- Trial name
- NCT06632613
- Testing
- ENN0403 capsules, low dose, ENN0403 capsules, high dose
- Where
- China
- Volunteers
- 200 people
- Sponsor
- EnnovaBio
Cardiac Surgery, Cardiopulmonary Bypass
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation…
- Trial name
- NCT02037555
- Testing
- AT-III (Human)
- Where
- 41 sites in United States
- Volunteers
- 425 people
- Sponsor
- Grifols Therapeutics LLC
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Myocardial Fibrosis
A Trial of Cardiac Injections of iMP Cells During CABG Surgery
Injury to the heart, which may occur following a heart attack or owing to the mechanical effect of high blood pressure, leads to scarring (fibrosis) of the heart muscle.
- Trial name
- NCT03515291
- Testing
- iMP cells, Control injection
- Volunteers
- 50 people
- Sponsor
- Cell Therapy Ltd.
Coronary Artery Bypass Surgery, Coronary Heart Disease
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00530361
- Testing
- Nesiritide
- Sponsor
- Scios, Inc.
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
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
Congestive Heart Failure
BMAC Enhanced Coronary Artery Bypass Grafting (CABG)
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
- Trial name
- NCT01061580
- Testing
- Harvest SmartPReP2 BMAC System
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Harvest Technologies
Heart Diseases, Hypertension, Pulmonary
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery.
- Trial name
- NCT00458276
- Testing
- tezosentan
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 274 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Post Cardiac Surgery Patients
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients.
- Trial name
- NCT00756119
- Where
- Russia
- Volunteers
- 26 people
- Sponsor
- Transonic Systems Inc.
Systolic Heart Failure, Peripheral Chemoreceptor Hypersensitivity
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure
The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.
- Trial name
- FIM (NCT01653821)
- Testing
- Carotid body excision
- Where
- Poland
- Volunteers
- 10 people
- Sponsor
- Noblewell
Heart Failure With Reduced Ejection Fraction
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation.
- Trial name
- RSA-PACE (NCT06384963)
- Testing
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability, Monotonic right atrial overdrive pacing
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 54 people
- Sponsor
- Ceryx Medical Australia
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC