Clinical trials: Cardiac Surgery Subjects
Heart Failure, Obesity
WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise
The goal of this study is to define how treatment of obesity impacts cardiometabolic performance during exercise in patients with established HFpEF or at risk for HFpEF.
- Conditions
- Heart Failure, Obesity, Weight Loss, Heart Failure With Preserved Ejection Fraction
- Trial name
- WTLOSS-EX (NCT06576050)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Massachusetts General Hospital
Bloodloss, Surgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
- Trial name
- CONSERV-1 (NCT00816023)
- Testing
- ecallantide
- Where
- 29 sites in United States, Canada
- Volunteers
- 276 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Cardiac Surgery Subjects
Ionized Calcium and Bleeding in Cardiac Surgery
This retrospective study investigates the association between perioperative plasma ionized calcium concentration and perioperative bleeding in open-heart surgery.
- Trial name
- NCT07634042
- Where
- Finland
- Volunteers
- 4,300 people
- Sponsor
- Helsinki University Central Hospital
Sternal Wound Infection, Mediastinitis
Rapid Sternal Closure System (TALON)
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function.
- Trial name
- TALON (NCT00638014)
- Testing
- Rapid Sternal Closure System, Conventional wire closure
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Duke University
Acute Kidney Injury
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
Subjects entering the study will have undergone cardiac surgery. Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study.
- Trial name
- ACT-AKI (NCT01602328)
- Testing
- AC607, Vehicle Only
- Where
- 31 sites in United States, Canada
- Volunteers
- 156 people
- Sponsor
- AlloCure Inc.
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
- Trial name
- NCT00125320
- Testing
- RSD1235
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Inc
Delirium - Postoperative, Cardiac Surgery
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium.
- Conditions
- Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist
- Trial name
- PROTEX (NCT06648681)
- Testing
- Lemborexant 5 mg
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- University of British Columbia
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Cardiac Surgery Subjects
Objective Measurement of the Mechanical Pain Threshold With an Algometer for Predicting Intraoperative Opioid Consumption in Patients Who Will be Operate by Thoracotomy and Sternotomy in Cardiac Surgery
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids. The objective of the study is to try to predict a patient's analgesic needs based on their objectively…
- Trial name
- NCT07513974
- Testing
- Measure of the minimal pain threshold with an algometer
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Université Libre de Bruxelles
Heart Failure With Preserved Ejection Fraction
Surgical Resection of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction
We believe that blocking of the Greater Splanchnic Nerve (GSN) will stop Sympathetic Nervous System (SNS) activity from reaching the splanchnic vessels and result in a redistribution of blood volume back into the splanchnic…
- Trial name
- NCT03715543
- Testing
- Surgical Resection of the Greater Splanchnic Nerve
- Where
- 2 sites in Czechia, Poland
- Volunteers
- 8 people
- Sponsor
- Noblewell
Heart Disease
Effect of GLP-1 on Postprandial Lipid Metabolism
Individuals with obesity have an increased risk for heart disease and diabetes. There are current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat diabetes.
- Trial name
- NCT01760772
- Testing
- Exendin-9, GLP-1, saline
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- David Dalessio
End Stage Cardiac Failure, Pulmonary Failure
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung…
- Conditions
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease, Morbid Obesity
- Trial name
- NCT00678834
- Testing
- To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects., To surgery patients, Tocotrienol capsules.
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Chandan K Sen
Coronary Disease
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.
- Trial name
- NCT00316212
- Testing
- INS50589 Intravenous Infusion
- Where
- 27 sites in United States
- Volunteers
- 160 people
- Sponsor
- Merck Sharp & Dohme LLC
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Acute Kidney Injury
A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- NCT02610283
- Testing
- QPI-1002
- Where
- 36 sites in United States, Canada and 1 more
- Volunteers
- 341 people
- Sponsor
- Quark Pharmaceuticals
Cardiac Surgery Subjects
Effect of PEEP on Cardiac Function
The purpose of this single-center, prospective study is to evaluate the physiologic effect of changes in PEEP on biventricular mechanics and RV-pulmonary arterial (RV-PA) coupling in adult patients undergoing cardiac surgery.
- Trial name
- NCT07531602
- Testing
- EIT Guided PEEP Trial
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Beth Israel Deaconess Medical Center
AKI - Acute Kidney Injury
Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine
This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery…
- Trial name
- EASE-AKI (NCT07661940)
- Testing
- SP16-3M
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Erlangen-Nürnberg Medical School