Clinical trials: Heart Surgery
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC).
- Trial name
- RADICAL (NCT05004077)
- Testing
- AMIODARONE
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Kevin W Hatton, MD, PhD
Hip Fracture, Myocardial Ischemia
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery.
- Conditions
- Hip Fracture, Myocardial Ischemia, Inflammation
- Trial name
- POST-OP Pilot (NCT02197065)
- Testing
- Atorvastatin
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Hospital for Special Surgery, New York
Coronary Artery Disease
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
This research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of PCSK9 level on that group to another group who receives conventional…
- Trial name
- NCT02674659
- Testing
- resistance training, aerobic training
- Volunteers
- 87 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
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
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
Postoperative Atrial Fibrillation
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF).
- Trial name
- NCT02132767
- Testing
- Amiodarone, DC-cardioversion, Rate Control
- Where
- 23 sites in United States, Canada
- Volunteers
- 523 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Postoperative Pain
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery…
- Trial name
- NCT04567407
- Testing
- Bilateral erector spinae blocks using ropivacaine
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Congenital Heart Defect
The Effects of Inhaled Nitric Oxide After Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance.
- Trial name
- NCT00945529
- Testing
- inhaled nitric oxide (iNO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ellen Spurrier
Heart Defects, Congenital
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to…
- Trial name
- NCT00543309
- Testing
- nesiritide, milrinone
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- John M Costello
Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery
Cardiac Rehabilitation Peer Mentorship
The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure
- Trial name
- NCT02204449
- Testing
- Cardiac Rehabilitation Peer Mentorship
- Where
- 2 sites in Canada
- Volunteers
- 94 people
- Sponsor
- University Health Network, Toronto
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
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
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
Coronary Artery Disease
On Versus Off Pump Myocardial Revascularization Study
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery.
- Trial name
- On-Off (NCT01290952)
- Testing
- Off-pump bypass surgery, On-pump bypass surgery
- Where
- 8 sites in Italy, Switzerland
- Volunteers
- 411 people
- Sponsor
- Medtronic Italia
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
Cardiac Surgery Intensive Care Treatment, Delayed Recovery From Anaesthesia
Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery
Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension…
- Conditions
- Cardiac Surgery Intensive Care Treatment, Delayed Recovery From Anaesthesia, Euthyroid Sick Syndrome, Cardiac Surgery Requiring Cardiopulmonary Bypass
- Trial name
- L-Thyroxine (NCT06660823)
- Testing
- L-thyroxine
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Kidney Injury
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline.
- Trial name
- NCT00921518
- Testing
- Sodium Bicarbonate
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Community Medical Center, Scranton, PA
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation