Clinical trials: Cardiac Surgical Procedures
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Robotic Cardiac Surgery Simulation
Robotic Cardiac Surgery Wet Lab Simulation Study
The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities.
- Trial name
- NCT05043064
- Testing
- Wet lab tasks
- Where
- Denmark
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Aalborg University Hospital
Coronary Artery Bypass, Cardiac Surgical Procedures
Thiamine as an Adjunctive Therapy in Cardiac Surgery
The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.
- Trial name
- NCT02322892
- Testing
- Thiamine, Normal saline solution
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Beth Israel Deaconess Medical Center
Cognitive Decline
Lidocaine For Neuroprotection During Cardiac Surgery
The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery.
- Trial name
- NCT00938964
- Testing
- Lidocaine
- Where
- 2 sites in United States
- Volunteers
- 550 people
- Sponsor
- Duke University
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
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
Endothelial Dysfunction
Endothelial Function After Cardiac Surgery
The purpose of this study is to evaluate whether patients receiving human albumin for plasma volume replacement during cardiac surgery have improved postoperative endothelial function compared to patients receiving 6%…
- Trial name
- NCT02882074
- Testing
- Human albumin, Hydroxyethyl starch
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- The Cleveland Clinic
Pain
Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery
This is a randomized clinical trial in patients undergoing robotic myocardial revascularization with intraoperative extubation. Patients will be randomized into placebo or intrathecal morphine groups to assess postoperative pain…
- Trial name
- NCT03241485
- Testing
- Intrathecal morphine
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- University of Chicago
Pain, Postoperative
Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
The Inova Heart and Vascular Institute (IHVI) perform over 300 coronary artery bypass graft (CABG) surgeries per year. While opioid medications are the institutional standard of care for post-operative pain therapy little is…
- Trial name
- INOVAOPIOID (NCT03679013)
- Testing
- Oral Gabapentin and Intravenous Acetaminophen (IV APAP), Opiate based pain regimen.
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Inova Health Care Services
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Bypass Grafting, Heart Valve Surgery
VItamin D Metabolism in SEnescent Cardiac Surgery Patients
Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of…
- Trial name
- VISE (NCT01378221)
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Coronary Artery Disease
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
The main aim of the study is to determine the effectiveness of an educational intervention designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac Rehabilitation Programs (CRPs) on actual CRP…
- Trial name
- MECRIS (NCT00356863)
- Testing
- Increasing awareness to cardiac rehabilitation programs
- Where
- Israel
- Volunteers
- 1,024 people
- Sponsor
- Sheba Medical Center
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Delirium
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery
Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different…
- Trial name
- DEXACET (NCT02546765)
- Testing
- IV acetaminophen & IV propofol, IV acetaminophen & IV dexmedetomidine
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Beth Israel Deaconess Medical Center
Coronary Artery Disease
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.
- Trial name
- PREVENT-AF (NCT03604432)
- Testing
- propylactic maze
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Corewell Health West
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
- Trial name
- NCT00914589
- Testing
- catridecacog
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 479 people
- Sponsor
- Novo Nordisk A/S
Chronic Kidney Disease, Cardiac Disease
Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Chronic kidney disease is an independent risk factor for cardiovascular disease associated with increased mortality rate during cardiac surgery in proportion to the kidney function.
- Trial name
- NCT04919564
- Testing
- Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL), NaCl 0.9%
- Where
- Indonesia
- Volunteers
- 90 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Delirium
Delirium and EuroSCORE II in Cardiac Surgery
The goal of this observational study is to find out the association between EuroSCORE II of Delirium in patients undergoing cardiac surgery.
- Trial name
- NCT05218720
- Testing
- EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Aga Khan University