Clinical trials: Heart Valve Replacement
Aortic Stenosis, Symptomatic Aortic Stenosis
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03466918
- Testing
- SAPIEN 3 THV with the Commander delivery system
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Heart Valve Diseases
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve…
- Trial name
- PAS (NCT01116037)
- Testing
- ATS 3f Aortic Bioprosthesis
- Where
- 6 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Medtronic Cardiovascular
Blood Loss, Surgical
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the…
- Trial name
- NCT00448864
- Testing
- Ecallantide
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Atrial Fibrillation
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.
- Trial name
- NCT02943785
- Testing
- Edoxaban-based Regimen, VKA-based Regimen
- Where
- 230 sites in United States, Austria and 12 more
- Volunteers
- 1,426 people
- Sponsor
- Daiichi Sankyo
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
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
Aortic Valve Disorder
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the…
- Trial name
- NCT02696226
- Testing
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of…
- Trial name
- NCT01319799
- Testing
- Open heart surgery
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Sahlgrenska University Hospital
Aortic Valve Stenosis
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe…
- Trial name
- NCT02701283
- Testing
- Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
- Where
- 87 sites in United States, Australia and 5 more
- Volunteers
- 2,223 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
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
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
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.
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Trial name
- GALILEO-4D (NCT02833948)
- Testing
- Acetylsalicylic acid, Clopidogrel, Rivaroxaban
- Where
- 25 sites in United States, Canada and 5 more
- Volunteers
- 231 people
- Sponsor
- ECRI bv
Cardiac Surgery-CABG, Cardiac Valve Replacement
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
- Trial name
- EPORT (NCT02802592)
- Testing
- Epogen, Normal Saline
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery
Sugammadex and Decreased Time to Extubation
The purpose of this study is to demonstrate faster time to extubation after arrival in the cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery bypass grafting (CABG), AVR and AVR/CABG…
- Trial name
- NCT03196167
- Testing
- Sugammadex
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Yale University
Aortic Valve Disease
Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement
The purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used at University of Ottawa Heart Institute…
- Trial name
- Tissue-Valve (NCT00465218)
- Testing
- Prophylaxis of Thrombosis after aortic valve replacement
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- Ottawa Heart Institute Research Corporation