Clinical trials: Cardiovascular Surgical Procedures
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
Analgesia, Obstetrical, Postpartum Hemorrhage
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control.
- Conditions
- Analgesia, Obstetrical, Postpartum Hemorrhage, Opioid Use, Nonsteroidals (NSAIDs)Toxicity
- Trial name
- NCT02509312
- Testing
- Ketorolac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
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
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
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
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
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Diabetic Foot Ulcers, Diabetic Foot Wounds
Using Santyl on Diabetic Foot Ulcers
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound.
- Trial name
- NCT01408277
- Testing
- Santyl, Control
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Healthpoint
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
Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery
Cardiac Rehabilitation Peer Mentorship
The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure
- Trial name
- NCT02204449
- Testing
- Cardiac Rehabilitation Peer Mentorship
- Where
- 2 sites in Canada
- Volunteers
- 94 people
- Sponsor
- University Health Network, Toronto
Atrial Fibrillation, Mitral Valve Insufficiency
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation.
- Conditions
- Atrial Fibrillation, Mitral Valve Insufficiency, Mitral Valve Stenosis
- Trial name
- NCT00903370
- Testing
- MVS, Ablation
- Where
- 21 sites in United States, Canada
- Volunteers
- 260 people
- Sponsor
- Annetine Gelijns
Shock, Cardiovascular Diseases
Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.
- Conditions
- Shock, Cardiovascular Diseases, Critical Illness
- Trial name
- MicroRESUS (NCT05330676)
- Testing
- coronary artery bypass grafting, valve repair/replacement
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Pennsylvania
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Coronary Artery Disease
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
The main aim of the study is to determine the effectiveness of an educational intervention designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac Rehabilitation Programs (CRPs) on actual CRP…
- Trial name
- MECRIS (NCT00356863)
- Testing
- Increasing awareness to cardiac rehabilitation programs
- Where
- Israel
- Volunteers
- 1,024 people
- Sponsor
- Sheba Medical Center
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
Anemia, Hematologic Diseases
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.
- Conditions
- Anemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases
- Trial name
- FOCUS (NCT00071032)
- Testing
- Liberal (10 g/dL) Transfusion Strategy, Restrictive (Symptomatic) Transfusion Strategy
- Where
- United States
- Volunteers
- 2,016 people
- Sponsor
- Rutgers, The State University of New Jersey