Clinical trials: Cardiovascular Surgery
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Mitral Valve Insufficiency
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when…
- Trial name
- ReChord (NCT02803957)
- Testing
- NeoChord DS1000, Surgical Mitral Valve Repair
- Where
- 14 sites in United States
- Volunteers
- 585 people
- Sponsor
- NeoChord
Coronary Artery Disease
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass…
- Trial name
- NCT00042081
- Testing
- CGT003 (E2F Duplex Decoy)
- Where
- 154 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Anesiva, Inc.
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.
Arterial Occlusive Diseases
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.
- Trial name
- NCT00115999
- Testing
- alfimeprase
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
Mitral Regurgitation
Valveclip® Transcatheter Mitral Valve Repair Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
- Trial name
- NCT05021614
- Testing
- Valveclip® Transcatheter mitral valve repair
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Aortic Arch Surgery
Near Infrared Spectroscopy (NIRS)
This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.
- Trial name
- NCT01429324
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nonin Medical, Inc
Thoracoabdominal Aortic Aneurysm
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with…
- Trial name
- NCT05954793
- Where
- 8 sites in Australia, New Zealand and 1 more
- Volunteers
- 30 people
- Sponsor
- JOTEC GmbH
Diabetic Retinopathy
Macular Edema Incidence/Severity Reduction With Nevanac
The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.
- Trial name
- NCT00939276
- Testing
- Nepafenac ophthalmic suspension, 0.1% (NEVANAC®), Nepafenac ophthalmic suspension vehicle
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Alcon Research
Sudden Cardiac Death, Ventricular Fibrillation
LifeVest Post-CABG Registry
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease…
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction
- Trial name
- NCT01448005
- Testing
- wearable defibrillator (LifeVest)
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Zoll Medical Corporation
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Elevated Cardiac Risk, Coronary Arteries Disease Risk
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with…
- Trial name
- CARVASAXe (NCT01120405)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in France
- Volunteers
- 600 people
- Sponsor
- Air Liquide Santé International
Blood Loss, Surgical
Quantra QPlus in Pediatric Cardiovascular Procedures
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
- Trial name
- NCT07597278
- Testing
- Quantra System
- Where
- 3 sites in United States
- Volunteers
- 160 people
- Sponsor
- HemoSonics LLC
Myocardial Ischemia, Coronary Artery Disease
Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) Surgery
In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.
- Trial name
- PERFECT (NCT00950274)
- Testing
- CD133+ autologous bone marrow stem cell
- Where
- 6 sites in Germany
- Volunteers
- 81 people
- Sponsor
- Miltenyi Biotec B.V. & Co. KG
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