Clinical trials: AORTIC VALVE DISEASES
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Assessment of Left Ventricular Torsion by Echocardiography Study
The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.
- Trial name
- LVTorsion (NCT00589836)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes.
- Trial name
- NCT01060020
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Aortic Valve Disorder
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis
- Trial name
- NCT01171625
- Testing
- Implantation of CEP Magna Ease Model 3300TFX
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 283 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Mitral Valve Disease
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.
- Trial name
- NCT05076604
- Testing
- Cardioplegia Solution, Microplegic Solution No. 1
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Washington University School of Medicine
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University
Hypertrophic Cardiomyopathy (HCM)
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- REDWOOD-HCM (NCT04219826)
- Testing
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg)
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 96 people
- Sponsor
- Cytokinetics
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Postoperative Atrial Fibrillation
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF).
- Trial name
- NCT02132767
- Testing
- Amiodarone, DC-cardioversion, Rate Control
- Where
- 23 sites in United States, Canada
- Volunteers
- 523 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Arterial Occlusion, Cardiovascular Diseases
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Hematoma
- Trial name
- NCT05637970
- Testing
- Perclose, Statseal
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, Los Angeles
Hyperglycemia, Aortic Valve Replacement
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with…
- Conditions
- Hyperglycemia, Aortic Valve Replacement, Aortic Stenosis, Cardiac Surgery
- Trial name
- NCT01187329
- Testing
- hyperinsulinemic normoglycemic clamp (HNC), control group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Hypertrophic Cardiomyopathy
Hypertrophic Regression With N-Acetylcysteine in HCM
The purpose of the sudy is to conduct a small study to gather the preliminary data for future lage scale clinical studies that will be designed test the potential beneficial effect of over-the counter study anti-oxidant drug…
- Trial name
- HALT (NCT01537926)
- Testing
- N-acetylcysteine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- The University of Texas Health Science Center, Houston
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Aortic Valve Disease
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
- Trial name
- NCT00619151
- Testing
- Top Hat, Regent
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sorin Group USA, Inc.