Clinical trials: Cardiovascular Surgical Procedure
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 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
Osteoarthritis, Cardiovascular Disease
Risk Factor Control Before Orthopedic Surgery
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
- Trial name
- OPTMIZE-OS (NCT01837069)
- Testing
- Metoprolol, Lisinopril, Atorvastatin
- Where
- United States
- Volunteers
- 198 people
- Sponsor
- NYU Langone Health
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
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
Arterial Thromboembolic Events, Atrial Fibrillation
Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much…
- Trial name
- NCT00786474
- Testing
- Dalteparin
- Where
- United States
- Volunteers
- 1,884 people, healthy volunteers welcome
- Sponsor
- Duke University
Spinal Ischemia, Stroke
The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals, yet they have all have failed when given after ischemic stroke in humans. A novel approach to ischemic neuroprotection is needed.
- Conditions
- Spinal Ischemia, Stroke, Neuroprotection
- Trial name
- DISC (NCT00647998)
- Testing
- Darbepoetin alfa, Standard care
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Pennsylvania
Atrial Fibrillation
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
- Trial name
- NCT01107730
- Testing
- Vitamin C, L-Carnitine
- Where
- Greece
- Volunteers
- 33 people
- Sponsor
- Attikon Hospital
Kidney Failure, Acute, Renal Replacement Therapy
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with…
- Trial name
- NCT00484354
- Testing
- Sodium bicarbonate, Normal saline, Bicarbonate
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Wake Forest University Health Sciences
Intracranial Arterial Stenosis, Intracranial Atherosclerosis
Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis
Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high…
- Conditions
- Intracranial Arterial Stenosis, Intracranial Atherosclerosis, Ischemic Stroke, Cerebral Angiogenesis
- Trial name
- ERSIAS (NCT01819597)
- Testing
- Encephaloduroarteriosynangiosis (EDAS)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Cedars-Sinai Medical Center
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Cardiovascular Disease
The Fibrin Pad CV Phase III Study
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
- Trial name
- NCT02040428
- Testing
- EVARREST™ Fibrin Sealant Patch, Topical hemostat
- Where
- 24 sites in United States, Australia and 3 more
- Volunteers
- 156 people
- Sponsor
- Ethicon, Inc.
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Wound Infection, Peripheral Arterial Disease
A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications
The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
- Conditions
- Wound Infection, Peripheral Arterial Disease, Aneurysm, Surgical Wound Dehiscence
- Trial name
- NCT02581904
- Testing
- Prevena Care, Dry gauze dressing care
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Thomas Jefferson University
Atrial Fibrillation
Medtronic Reveal XT Study
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram…
- Trial name
- NCT01526343
- Testing
- Reveal XT implantation
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Washington University School of Medicine
Vascular Disease
Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees
To design, validate and prove cost-effectiveness of a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the…
- Trial name
- PROSPECT (NCT01965860)
- Testing
- additional curriculum (E-learning + simulation), additional E-learning
- Where
- Belgium
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University Ghent
Mitral Annular Calcification
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at…
- Trial name
- SITRAL (NCT02830204)
- Testing
- Mitral Valve Replacement (MVR) with Sapien3
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute