Clinical trials: Cardiovascular Surgery
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
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Postoperative Complications, Memory Disorders
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic…
- Trial name
- NCT00736125
- Testing
- pulsatile saline lavage, carbon dioxide lavage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kinamed Incorporated
Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events…
- Trial name
- NCT07164833
- Testing
- BX-001N Experimental group 1, BX-001N Experimental group 2
- Where
- 8 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- Bilix Co.,Ltd.
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.
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.
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Heart; Dysfunction Postoperative, Cardiac Surgery
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor.
- Trial name
- NCT01289470
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Nonin Medical, Inc
Atrial Fibrillation, Surgery
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a…
- Conditions
- Atrial Fibrillation, Surgery, Ablation of Atrial Fibrillation, Clamp Study
- Trial name
- NCT06355063
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 6 sites in Austria, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Pulse Biosciences, Inc.
Pressure Ulcer, Arterial Ulcers
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected…
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers
- Trial name
- NCT05646121
- Testing
- Suprasorb® A + Ag wound dressing and rope
- Where
- 8 sites in Poland
- Volunteers
- 99 people
- Sponsor
- Lohmann & Rauscher
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Chronic Kidney Diseases, End Stage Renal Disease
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a…
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Trial name
- SAVE-FistulaS (NCT06001827)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Where
- 28 sites in United States
- Volunteers
- 600 people
- Sponsor
- VenoStent
Myocardial Ischemia
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
- Trial name
- ATHENA II (NCT02052427)
- Testing
- Celution System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Cytori Therapeutics
Thromboembolism
REVIparin-BRIDging-in a General Practice Setting in GErmany
In view of the fact that little is known about the pre- and post-interventional coagulation management of phenprocoumon patients with reviparin at general practices in Germany, an observational study is being initiated to…
- Trial name
- REVIBRIDGE (NCT02579122)
- Where
- 11 sites in Germany
- Volunteers
- 77 people
- Sponsor
- Mylan Inc.
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.
Hypertension, Pulmonary
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated…
- Trial name
- EAS (NCT01784562)
- Testing
- Adempas (Riociguat, BAY63-2521)
- Where
- 102 sites in United States, Austria and 18 more
- Sponsor
- Bayer
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies