Clinical trials: Cardiac Surgical Procedures
Acute Kidney Injury
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after…
- Trial name
- KIDPROAM (NCT01245595)
- Testing
- Aminophylline
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Stanford University
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
Heart; Dysfunction Postoperative, Cardiac Surgery
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery
- Trial name
- NCT01352416
- Testing
- Ranolazine
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Corewell Health East
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.
Mitral Valve Insufficiency
The Use of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
- Trial name
- NCT02180893
- Testing
- Paravertebral Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Reperfusion Injury
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.
- Trial name
- VitaminC (NCT01167569)
- Testing
- Ascorbic Acid, 5 % Dextrose Water or Normal Saline
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Rutgers, The State University of New Jersey
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
Fluid Overload, Fluid Loss
Atrial Natriuretic Peptide in Assessing Fluid Status
Biomarkers can play a significant role in fluid status assessment intraoperatively.
- Conditions
- Fluid Overload, Fluid Loss, Volume Overload, Cardiac Disease
- Trial name
- NCT05070819
- Testing
- pro-ANP
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Petrovsky National Research Centre of Surgery
Infection
The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin.
- Trial name
- NCT02051595
- Testing
- Vancomycin concentrations
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Florida
Coronary Artery Bypass Graft Redo, Heart Valve Diseases
SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of brain infarctions due to the activation of…
- Trial name
- SONORESCUE (NCT01591018)
- Testing
- sonolysis, cardiac surgery
- Where
- Czechia
- Volunteers
- 120 people
- Sponsor
- University Hospital Ostrava
Pain, Postoperative
Effect of Ketamine on Analgesia Post-Cardiac Surgery
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving…
- Trial name
- NCT02925858
- Testing
- Normal Saline Flush, 0.9% Injectable Solution_#1, Ketamine Hydrochloride
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Jewish General Hospital
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
Complication of Surgical Procedure
Factors Responsible for the Effectiveness of the Lund De-airing Technique
The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of…
- Trial name
- NCT01757704
- Testing
- Open pleurae & conventional filling of heart, Intact pleurae & staged filling of heart
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Lund University
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Heart Defects, Congenital, Cardiopulmonary Bypass
Nesiritide Use Following Cardiac Surgery in Infants
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
- Trial name
- NCT00281671
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Boston Children's Hospital
Cardiac Surgery, Cardiopulmonary Bypass
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
- Trial name
- COLCHIRCARD (NCT02584868)
- Testing
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
- Where
- Belgium
- Volunteers
- 88 people
- Sponsor
- Queen Fabiola Children's University Hospital
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
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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