Clinical trials: Surgery, Cardiovascular
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-ABDO (NCT00679588)
- Testing
- Semuloparin Sodium, Enoxaparin sodium
- Where
- 270 sites in United States, Argentina and 37 more
- Volunteers
- 4,413 people
- Sponsor
- Sanofi
Peripheral Vascular Disease
Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
- Trial name
- NCT00154141
- Testing
- Fibrin sealant (FS2)
- Where
- 17 sites in United States, United Kingdom
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
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
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
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.
Coronary Artery Disease
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
- Trial name
- NCT00364390
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Theregen, Inc.
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-HIP1 (NCT00697099)
- Testing
- Semuloparin sodium, Enoxaparin sodium
- Where
- 30 sites in United States, Argentina and 28 more
- Volunteers
- 2,326 people
- Sponsor
- Sanofi
Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require…
- Trial name
- FCAD02 (NCT00838383)
- Testing
- sitaxsentan (Thelin)
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Pfizer
Arterial Occlusive Diseases
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Primary objective: To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee…
- Trial name
- NCT00174759
- Testing
- Clopidogrel
- Where
- 14 sites in Australia, Austria and 12 more
- Volunteers
- 1,460 people
- Sponsor
- Sanofi
Atrial Fibrillation
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
Cranial Aneurysm
Navigation Support With Mixed Reality With CORTEXPLORER MED
During the last 15 years, neuronavigation has become an essential neurosurgical tool for pursuing minimal invasiveness and safety.
- Trial name
- CXmed (NCT05269498)
- Testing
- CORTEXPLORER MED
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- cortEXplore GmbH
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 (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Venous Thromboembolism
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP)…
- Trial name
- NCT00934167
- Testing
- heparin sodium - Hipolabor, Heparin sodium - APP
- Where
- Brazil
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil
Venous Thromboembolism
Dose-confirmatory Bridging Study in Total Hip Replacement
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing…
- Trial name
- NCT01205932
- Testing
- Rivaroxaban (BAY59-7939), Enoxaparin
- Where
- 41 sites in Japan
- Volunteers
- 402 people
- Sponsor
- Bayer
Heart Disease, Cardiac Surgery
Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery
This prospective, single-arm study aims to evaluate the effectiveness of Phase I cardiac rehabilitation based on remote electrocardiographic (ECG) monitoring in patients undergoing heart surgery.
- Conditions
- Heart Disease, Cardiac Surgery, Cardiac Rehabilitation
- Trial name
- NCT07736066
- Testing
- MEMO Patch, Phase I Cardiac Rehabilitation Program
- Where
- South Korea
- Volunteers
- 22 people
- Sponsor
- HUINNO Co., Ltd
Aortic Aneurysm, Aortic Dissection
Thoraflex™ Hybrid IDE Study
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of…
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Rupture
- Trial name
- NCT02724072
- Testing
- Thoraflex™ Hybrid Device
- Where
- 12 sites in United States
- Volunteers
- 84 people
- Sponsor
- Bolton Medical