Clinical trials: Cardiovascular Surgical Procedures
Coronary Artery Disease
The MASS COMM Post-Randomization Phase Cohort Study
The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than…
- Trial name
- NCT02072421
- Testing
- PCI
- Where
- 10 sites in United States
- Volunteers
- 2,879 people
- Sponsor
- Baim Institute for Clinical Research
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Atrial Fibrillation
Medtronic Reveal XT Study
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram…
- Trial name
- NCT01526343
- Testing
- Reveal XT implantation
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Washington University School of Medicine
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Parapneumonic Effusion, Empyema, Pleural
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus…
- Conditions
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- Trial name
- NCT03583931
- Testing
- VATS Decortication, Fibrinolytic Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Denver Health and Hospital Authority
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
Diabetic Foot Ulcers, Diabetic Foot Wounds
Using Santyl on Diabetic Foot Ulcers
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound.
- Trial name
- NCT01408277
- Testing
- Santyl, Control
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Healthpoint
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Adrenergic Beta-Receptor Blockader, Troponin Levels
Pilot - Peri-operative Beta Blockade
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart…
- Conditions
- Adrenergic Beta-Receptor Blockader, Troponin Levels, Cardiomyopathy, Post-surgical
- Trial name
- NCT02746575
- Testing
- metoprolol
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Washington University School of Medicine
Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
PURPOSE OF RESEARCH: Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients.
- Trial name
- NCT00757003
- Testing
- Endovascular Stent-graft repair of descending thoracic aorta
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Shock, Surgical, Shock
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways.
- Conditions
- Shock, Surgical, Shock, Hypotension and Shock, Kidney Transplant; Complications
- Trial name
- NCT04529005
- Testing
- Angiotensin II
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Illinois at Chicago
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
Atrial Fibrillation
Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients
Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation.
- Trial name
- SCALAF (NCT00703157)
- Testing
- Catheter Ablation, Surgical Ablation
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Congenital Heart Disease, Disorder of Fetus or Newborn
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition…
- Trial name
- NCT01579513
- Testing
- Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medical University of South Carolina
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
Venous Thromboembolism, Venous Thrombosis
Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism
The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential…
- Trial name
- IPCSUPER (NCT03044574)
- Testing
- SCD, GCS, LMWH
- Where
- 2 sites in Russia
- Volunteers
- 407 people
- Sponsor
- Pirogov Russian National Research Medical University
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices