Clinical trials: Cardiac Surgery Patients
Atrial Fibrillation
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
- Trial name
- Neural-AF-2 (NCT05426759)
- Testing
- Pulsed Field Ablation of epicardial Ganglionated Plexi.
- Where
- Georgia
- Volunteers
- 12 people
- Sponsor
- Atrian Medical 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.
Coronary Artery Disease
GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT03635606
- Where
- 3 sites in United States
- Volunteers
- 370 people
- Sponsor
- Sapere Bio
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Cardiovascular Diseases
Use of the Quantra QPlus Sytem in Cardiac Surgery
Single center retrospective study evaluating the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.
- Trial name
- NCT05501730
- Testing
- Quantra QPlus System
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- HemoSonics LLC
CPB, Oral Anticoagulant Therapy
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
- Trial name
- NCT00151853
- Testing
- PPSB-SD
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Prothya Biosolutions
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Post-Operative Complications in Cardiac Surgery
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: Patient reported outcomes (PRO), using the EQ-5D questionnaire Clinical outcomes
- Trial name
- NCT06092970
- Testing
- RBT-1
- Where
- 39 sites in United States, Canada
- Volunteers
- 353 people
- Sponsor
- Renibus Therapeutics, Inc.
Acute Kidney Injury
Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated- Acute Kidney Injury
This is a Phase 2, dose-ranging, double-blind, double-dummy, placebo-controlled, randomized study preceded by an open label safety run-in, in patients at high risk for Cardiac Surgery Associated - Acute Kidney Injury (CSA-AKI)…
- Trial name
- CSA-AKI (NCT07625553)
- Testing
- R2R01
- Where
- Italy
- Volunteers
- 430 people
- Sponsor
- River 2 Renal Corp.
Postoperative Hemorrhage
Aprotinin US Special Access Protocol
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass…
- Trial name
- NCT00611845
- Testing
- Aprotinin (Trasylol, BAYA0128)
- Where
- 17 sites in United States
- Sponsor
- Bayer
Acute Kidney Injury Following Cardiac Surgery
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac…
- Trial name
- NCT05524051
- Testing
- TIN816
- Where
- 37 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Hypertension
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2)…
- Trial name
- NCT03122730
- Testing
- VentaProst
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Aerogen Pharma Limited
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Cardiac Disease, Post Surgery Patients
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest…
- Trial name
- NCT01616017
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Transonic Systems Inc.
Cardiac Surgery, Coronary Artery Bypass
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery
- Trial name
- NCT01256372
- Testing
- AP214
- Where
- Denmark
- Volunteers
- 77 people
- Sponsor
- Action Pharma A/S
Myocardial Ischemia
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
- Trial name
- ATHENA II (NCT02052427)
- Testing
- Celution System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Cytori Therapeutics
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.