Clinical trials: Cardiac Surgical Procedures
Postoperative Delirium, Aortic Valve Stenosis
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care…
- Trial name
- IPOD-AV (NCT03950440)
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgical Procedures
The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)
Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass.
- Trial name
- NCT02060838
- Testing
- Acute normovolemic hemodilution (ANH)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Aymen N Naguib
Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based…
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Trial name
- PREHAB (NCT02219815)
- Testing
- Prehab Intervention
- Where
- 5 sites in Canada
- Volunteers
- 89 people
- Sponsor
- St. Boniface Hospital
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
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
C.Surgical Procedure; Cardiac
Prospective Trial of Tranexamic Acid in Cardiac Surgery
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown.
- Trial name
- NCT01998438
- Testing
- Tranexamic Acid
- Where
- China
- Volunteers
- 955 people
- Sponsor
- Hongwen Ji
Morbid Obesity
McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients undergoing non-cardiac surgery.
- Trial name
- NCT03467048
- Testing
- McGrath videolaryngoscopy, Direct laryngoscopy
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- The Cleveland Clinic
Heart Diseases, Hyperglycemia
Remifentanil and Glycemic Response in Cardiac Surgery
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period.
- Trial name
- NCT02349152
- Testing
- Remifentanil, Fentanyl
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Kathirvel Subramaniam
Cardiac Output, Low
Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.
Cardiac output (CO) monitoring is an important tool in critically ill patients with haemodynamic instability. Traditionally, this has been accomplished using the pulmonary artery catheter (PAC).
- Trial name
- NCT03394768
- Testing
- No additional intervention
- Where
- Singapore
- Volunteers
- 26 people
- Sponsor
- Changi 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)
Cardiac Disease, Cardiac Surgery
Platelet Transfusion During Neonatal Open Heart Surgery
Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early…
- Conditions
- Cardiac Disease, Cardiac Surgery, Cardiopulmonary Bypass, Platelet Transfusion
- Trial name
- CPB (NCT03045068)
- Testing
- Platelet Transfusion, FFP and Cryoprecipitate, PRBC and cell saver Transfusion
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- The University of Texas Health Science Center, Houston
Analgesia, Sternotomy
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without…
- Trial name
- NCT05676814
- Testing
- Pecto-intercostal Fascial Block (PIFB), PIFB with adjuvants
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Wake Forest University Health Sciences
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Coronary Artery Bypass Surgery, Postoperative Complications
Glutamate for Metabolic Intervention in Coronary Surgery II
The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients undergoing moderate to high-risk coronary artery…
- Conditions
- Coronary Artery Bypass Surgery, Postoperative Complications, Heart Failure
- Trial name
- GLUTAMICSII (NCT02592824)
- Testing
- glutamate infusion, saline infusion
- Where
- 4 sites in Sweden
- Volunteers
- 321 people
- Sponsor
- University Hospital, Linkoeping
Minimally Invasive Surgical Procedures, Laparoscopy
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery.
- Conditions
- Minimally Invasive Surgical Procedures, Laparoscopy, Leakage of Cardiac Device
- Trial name
- RELAP (NCT05363813)
- Testing
- M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System)
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 245 people
- Sponsor
- Microline Surgical, Inc.
Diabetes Mellitus, Type 2, Hyperglycemia
Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery
This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo.
- Trial name
- NCT01970462
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Kathleen Dungan
Atrial Fibrillation, Pericardial Effusion
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study
The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Tube Clearance (ATC) technology in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to…
- Conditions
- Atrial Fibrillation, Pericardial Effusion, Pleural Effusion, Hemothorax
- Trial name
- NCT02808897
- Testing
- Standard drainage, Active Tube Clearance drainage
- Where
- 2 sites in Canada
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- Montreal Heart Institute
Congenital Heart Disease
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs.
- Trial name
- NCT00850720
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Hemorrhage, Surgical, Hemorrhage Postoperative
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Trial name
- STAR-D (NCT05093504)
- Testing
- DrugSorb-ATR system
- Where
- 27 sites in United States
- Volunteers
- 9 people
- Sponsor
- CytoSorbents, Inc