Clinical trials: Cardiovascular Surgical Procedure
Vascular Disease
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels…
- Trial name
- StEPS (NCT00759681)
- Testing
- ArterX Surgical Sealant, Gelfoam and Thrombin
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Tenaxis Medical, Inc.
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
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
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.
Surgical Blood Loss, Postoperative Blood Loss
Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated.
- Trial name
- REPLACE (NCT01475669)
- Testing
- Fibrinogen Concentrate (Human) (FCH)
- Where
- 35 sites in Austria, Brazil and 9 more
- Volunteers
- 152 people
- Sponsor
- CSL Behring
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Acute Kidney Injury, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery
- Trial name
- NCT04585555
- Testing
- Accuryn Monitoring System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Potrero Medical
Hepatitis C
WEUSKOP5410: Observational Study in ENABLE Clinical Trials
Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current mainstay of treatment is combination therapy with pegylated interferon and ribavarin.
- Trial name
- NCT01458080
- Testing
- eltrombopag
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Atrial Fibrillation
Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System…
- Trial name
- CURE-AF/Perst (NCT00506493)
- Testing
- Cardioblate Surgical Ablation System, Surgical RF Ablation
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Medtronic Cardiac Surgery
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
Thromboembolic Event, FDP
Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications
The purpose of this study is to compare the safety of freeze-dried plasma (FDP), known as EZPLAZ, with conventional plasma in adults who need a plasma transfusion.
- Trial name
- SAFE-PLASMA (NCT07840352)
- Testing
- Freeze-Dried Plasma, Conventional Plasma
- Volunteers
- 867 people
- Sponsor
- Teleflex
Atrial Fibrillation
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical…
- Trial name
- NCT00111488
- Testing
- Flex 4 and Generator
- Where
- 21 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Wounds, Pressure Ulcer
Kerecis Real-World Fish Skin Graft Registry
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- ISACOD (NCT06384183)
- Testing
- Kerecis Fish Skin Graft
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Kerecis Ltd.