Clinical trials: Cardiovascular Surgical Procedure
Intubation, Cardiovascular Surgical Procedure
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the…
- Trial name
- NCT04782817
- Testing
- Recommendation for high flow nasal cannula oxygen therapy order set, Provider choice usual care order set
- Where
- United States
- Volunteers
- 3,568 people
- Sponsor
- Vanderbilt University Medical Center
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
Diabetic Foot Ulcer
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement.
- Trial name
- NCT04633642
- Testing
- Ultrasound group, Surgical group
- Where
- 2 sites in Spain
- Volunteers
- 51 people
- Sponsor
- Universidad Complutense de Madrid
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
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.
Atherosclerosis, Stroke
Carotid Revascularization Endarterectomy Versus Stenting Trial
The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of…
- Conditions
- Atherosclerosis, Stroke, Carotid Stenosis, Cerebral Infarction
- Trial name
- CREST (NCT00004732)
- Testing
- Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
- Where
- 115 sites in United States, Canada
- Volunteers
- 2,502 people
- Sponsor
- Rutgers, The State University of New Jersey
Coronary Artery Disease
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.
- Trial name
- PREVENT-AF (NCT03604432)
- Testing
- propylactic maze
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Corewell Health West
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Congenital Heart Disease
Paravertebral Nerve Blocks in Neonates
This study is a prospective, randomized, non-blinded clinical trial examining the use of paravertebral peripheral nerve block in the neonatal and infant populations.
- Trial name
- NCT03408340
- Testing
- Paravertebral Nerve Block, Standard of Care Anesthesia
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Emory University
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Parapneumonic Effusion, Empyema, Pleural
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus…
- Conditions
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- Trial name
- NCT03583931
- Testing
- VATS Decortication, Fibrinolytic Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Denver Health and Hospital Authority
Bleeding, Blood Loss, Surgical
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and…
- Conditions
- Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates
- Trial name
- NCT02557672
- Testing
- Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
Ovarian Cancer
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women…
- Trial name
- NCT00740116
- Testing
- Tranexamic acid, 0.9% NaCl solution
- Where
- 3 sites in Sweden
- Volunteers
- 100 people
- Sponsor
- Preben Kjolhede, MD, professor
Coronary Disease, Coronary Stenosis
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in…
- Trial name
- FAME 3 (NCT02100722)
- Testing
- FFR guided PCI, CABG, Resolute Integrity Stent
- Where
- 46 sites in United States, Australia and 14 more
- Volunteers
- 1,500 people
- Sponsor
- Stanford University
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery