Clinical trials: Surgery, Cardiovascular
Anemia, Venous Thrombosis
A Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Patients Undergoing Major Elective Spinal Surgery (SPINE Study)
This study is designed to investigate the incidence of deep vein thrombosis in patients receiving a perisurgical regimen of epoetin alfa (PROCRIT®) as compared to patients receiving standard of care blood conservation management.
- Trial name
- NCT00211146
- Testing
- epoetin alfa
- Volunteers
- 680 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Coronary Artery Bypass Surgery, Coronary Heart Disease
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00530361
- Testing
- Nesiritide
- Sponsor
- Scios, Inc.
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Coagulation
Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.
- Trial name
- NCT03139097
- Testing
- Quantra System
- Where
- 3 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- HemoSonics LLC
Intracerebral Hemorrhage, Cerebral Hemorrhage
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute…
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage
- Trial name
- ENRICH (NCT02880878)
- Testing
- Early Surgical Hematoma Evacuation
- Where
- 36 sites in United States
- Volunteers
- 300 people
- Sponsor
- Nico Corporation
Stroke, Hemorrhagic Strokes
Evaluation of Clinical Effectiveness and Safety of Locaste 8F Guiding Catheter in Neurovascular Interventional Surgery
The Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024.
- Trial name
- NCT06917248
- Where
- 2 sites in China
- Volunteers
- 113 people
- Sponsor
- Keuro MedTech
Venous Thromboembolism
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily.
- Trial name
- NCT00657150
- Testing
- Enoxaparin, Dabigatran etexilate
- Where
- 108 sites in United States, Australia and 17 more
- Volunteers
- 2,055 people
- Sponsor
- Boehringer Ingelheim
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
Deep Vein Thrombosis
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
- Trial name
- NCT02368314
- Testing
- Sodium Enoxaparine
- Where
- Russia
- Volunteers
- 124 people
- Sponsor
- Biocad
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Medical Need of OAC Reversal
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
- Trial name
- NCT03254147
- Testing
- warfarin, dabigatran, Apixaban
- Where
- Japan
- Volunteers
- 53,969 people
- Sponsor
- Boehringer Ingelheim
Cardiovascular Bleeding, Vascular Bleeding
The Bioseal Vascular Study
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
- Conditions
- Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage
- Trial name
- NCT02094885
- Testing
- Bioseal Fibrin Sealant, Manual Compression
- Where
- 9 sites in China
- Volunteers
- 252 people
- Sponsor
- Ethicon, Inc.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Acute Coronary Syndrome (ACS)
Maintenance of Platelet Inhibition With Cangrelor
The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.
- Trial name
- Bridge (NCT00767507)
- Testing
- cangrelor
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- The Medicines Company
Mitral Valve Insufficiency
Multicenter International Trial Ring AnnulopLasty
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included.
- Trial name
- MITRAL (NCT00727012)
- Testing
- mitral valve repair (SJM® Rigid Saddle Ring)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Abbott Medical Devices
CABG-patients, Heart Failure
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem…
- Conditions
- CABG-patients, Heart Failure, Myocardial Infarction (MI)
- Trial name
- CARDIOMESH II (NCT06956807)
- Testing
- VB-C01 cellularised patch
- Where
- Poland
- Volunteers
- 10 people
- Sponsor
- Viscofan
Diabetic Foot Ulcers, Foot Wounds
Santyl vs. Sharp Debridement of Diabetic Foot Wounds
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
- Trial name
- NCT01056198
- Testing
- Santyl, Control
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Healthpoint
Peripheral Vascular Disease, Femoral Occlusive Disease
New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results.
- Conditions
- Peripheral Vascular Disease, Femoral Occlusive Disease, Femoropopliteal Occlusive Disease, Aortoiliac Atherosclerosis
- Trial name
- VJ (NCT01514916)
- Testing
- mechanical anastomosis without suture
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Ab Medica Spa
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH