Clinical trials: Cardiovascular Surgery
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Varicose Veins
The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear.
- Trial name
- NCT01195623
- Testing
- preoperative duplex examination, Preoperative duplex
- Where
- Sweden
- Volunteers
- 293 people
- Sponsor
- Uppsala University Hospital
Major Surgery, Coronary Artery Disease
Vitamins in Nitrous Oxide Study
In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of cardiac complications after surgery in patients with a specific genetic profile (mutations in the MTHFR gene) and if this risk can be…
- Trial name
- VINO (NCT00655980)
- Testing
- Vitamin B12 and folic acid, standard of care
- Where
- United States
- Volunteers
- 687 people
- Sponsor
- Washington University School of Medicine
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
Intubation, Cardiovascular Surgical Procedure
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the…
- Trial name
- NCT04782817
- Testing
- Recommendation for high flow nasal cannula oxygen therapy order set, Provider choice usual care order set
- Where
- United States
- Volunteers
- 3,568 people
- Sponsor
- Vanderbilt University Medical Center
Atrial Fibrillation, Stroke
Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- NEW-AF (NCT03702582)
- Testing
- Rivaroxaban, Warfarin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Dissection of Thoracic Aorta
Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion…
- Trial name
- NCT01369732
- Testing
- recombinant human erythropoietin, saline
- Where
- South Korea
- Volunteers
- 66 people
- Sponsor
- Yonsei University
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
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Atrial Fibrillation, Atrial Flutter
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major thoracic surgery.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Myocardial Injury After Non-Cardiac Surgery
- Trial name
- COP-AF (NCT03310125)
- Testing
- Active Colchicine
- Where
- 46 sites in United States, Austria and 9 more
- Volunteers
- 3,209 people
- Sponsor
- Population Health Research Institute
Coronary Artery Bypass, Myocardial Infarction
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.
- Conditions
- Coronary Artery Bypass, Myocardial Infarction, Ventricular Dysfunction, Left, Stroke
- Trial name
- RED-CABG (NCT00872001)
- Testing
- Acadesine, Normal Saline
- Volunteers
- 3,080 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well…
- Trial name
- SPRINT (NCT00799604)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medicines Company
Arthroplasty, Replacement, Knee, Venous Thrombosis
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism…
- Trial name
- NCT00246025
- Testing
- Dabigatran etexilate
- Where
- 38 sites in Japan
- Volunteers
- 512 people
- Sponsor
- Boehringer Ingelheim
Deep-Venous Thrombosis, Pulmonary Embolism
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (VTE) prophylaxis in patients…
- Conditions
- Deep-Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
- Trial name
- NCT02970032
- Testing
- Real time heparin dose adjustment, Standard heparin dose
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Utah
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
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
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
Deep Vein Thrombosis, Pulmonary Embolism
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare…
- Trial name
- ADVANCE-2 (NCT00452530)
- Testing
- Enoxaparin, Apixaban
- Where
- 122 sites in Austria, Belgium and 25 more
- Volunteers
- 3,221 people
- Sponsor
- Bristol-Myers Squibb