Clinical trials: Surgery, Cardiovascular
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Peripheral Arterial Disease
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular…
- Trial name
- NCT05625711
- Testing
- The endovascular interventional surgical instrument control system
- Volunteers
- 260 people
- Sponsor
- Shanghai Operation Robot Co., Ltd.
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization
- Trial name
- NCT00157716
- Testing
- (MC-1) Pyridoxal-5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 900 people
- Sponsor
- Medicure
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
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 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
Stroke, Surgery
The Neuralert Stroke Monitor Pilot Trial
This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care.
- Trial name
- NCT06368193
- Testing
- Neuralert Monitor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Neuralert Technologies LLC
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 Disease, Multiple Organ Dysfunction Syndrome
Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass
More than 1 million people undergo cardiac surgery each year worldwide. Cardiac surgeries still in most cases require cardiopulmonary bypass, use of myocardial protection against aortic clamping and creation of cardioplegic…
- Trial name
- NCT06659289
- Testing
- Efferon LPS
- Where
- Russia
- Volunteers
- 14 people
- Sponsor
- Efferon JSC
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or…
- Trial name
- NCT05784337
- Testing
- Mi-thos® Transcatheter Mitral Valve Replacement System
- Where
- 2 sites in China
- Volunteers
- 11 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
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
Reversal of Coagulopathy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
Venous Thromboembolism
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
This study is phase 3 study for prevention of VTE in patients with abdominal surgery.
- Trial name
- NCT00333021
- Testing
- Fondaparinux sodium, GSK576428
- Where
- 18 sites in Japan
- Volunteers
- 127 people
- Sponsor
- GlaxoSmithKline
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Coronary Artery Bypass Surgery, Coronary Heart Disease
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00653042
- Testing
- Nesiritide
- Volunteers
- 305 people
- Sponsor
- Scios, Inc.