Clinical trials: Open-heart Surgery
Pulmonary Hypertension
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary…
- Trial name
- NCT05699486
- Testing
- PDNO
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Attgeno AB
Hypertension
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well…
- Trial name
- SPRINT (NCT00799604)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medicines Company
Coronary Heart Disease
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids.
- Trial name
- NCT01654653
- Testing
- Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Adult Cardiac Surgery
Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial
This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery.Primary…
- Trial name
- NCT06146426
- Testing
- Early diet resumption
- Where
- Qatar
- Volunteers
- 196 people
- Sponsor
- Hamad Medical Corporation
Postoperative Pain
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs.
- Trial name
- NCT06271265
- Testing
- EXPAREL, bupivacaine
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Congenital Heart Disease in Children
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe…
- Trial name
- NCT05647161
- Testing
- BAX602, No Intervention
- Where
- 6 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Baxter Healthcare Corporation
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Stroke
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual…
- Trial name
- NCT00962702
- Testing
- LAAx TigerPaw System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- LAAx, Inc.
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
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
Hemostasis, Hemostatic Techniques
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of…
- Trial name
- NCT06664788
- Testing
- ETHIZIA, SURGICEL Original
- Where
- 7 sites in United States, Netherlands
- Volunteers
- 108 people
- Sponsor
- Ethicon, Inc.
Coronary Artery Disease
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
- Trial name
- NCT00364390
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Theregen, Inc.
CABG-patients, Heart Failure
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem…
- Conditions
- CABG-patients, Heart Failure, Myocardial Infarction (MI)
- Trial name
- CARDIOMESH II (NCT06956807)
- Testing
- VB-C01 cellularised patch
- Where
- Poland
- Volunteers
- 10 people
- Sponsor
- Viscofan
Heart Disease
A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical…
- Trial name
- MiniMetrxics (NCT00500929)
- Testing
- CMI X-11S
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Cardiometabolics
Kidney Injury Following Open-Chest Cardiac Surgery
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury.
- Trial name
- POINTER (NCT06475274)
- Testing
- RMC-035
- Where
- 19 sites in Canada, Czechia and 2 more
- Volunteers
- 170 people
- Sponsor
- Guard Therapeutics AB
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.
Mitral Valve Regurgitation
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
- Trial name
- MAARS (NCT00554151)
- Testing
- Adjustable Annuloplasty Ring
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Arteriosclerosis of Coronary Artery Bypass Graft
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
This clinical study has been developed to evaluate the clinical outcomes in patients undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a minimally invasive coronary bypass procedure that…
- Trial name
- MICS (NCT01334866)
- Testing
- Minimally invasive coronary artery bypass graft surgery
- Where
- 2 sites in United States, Canada
- Volunteers
- 91 people
- Sponsor
- Medtronic Cardiovascular