Clinical trials: Surgical Valve Replacement
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 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
Aortic-valve Replacement
Behavior of Valve Leaflets Following Aortic Valve Implant
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve…
- Trial name
- BELIEVE (NCT03200574)
- Testing
- 4D Cardiac CT Scan, LivaNova Bioprothetic Aortic Valve Implant
- Where
- 11 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Corcym S.r.l
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
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
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
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
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
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
To confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475709
- Testing
- Trifecta Aortic Heart Valve
- Where
- 18 sites in United States
- Volunteers
- 1,022 people
- Sponsor
- Abbott Medical Devices
Postoperative Kidney Injury
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery.
- Trial name
- SHARP (NCT02192502)
- Testing
- human albumin 5%, HES 130/0.4 (Voluven)
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- The Cleveland Clinic
Atrial Fibrillation New Onset, Hemorrhage
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
- Conditions
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia
- Trial name
- NCT01590979
- Testing
- Ranolazine
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Northwell Health
Mitral Valve or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.