Clinical trials: Aortic Valve
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
Hypertrophic Cardiomyopathy
Ranolazine for the Treatment of Chest Pain in HCM Patients
The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy.
- Trial name
- RHYME (NCT01721967)
- Testing
- Ranolazine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Duke University
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 Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or…
- Trial name
- Enable (NCT01116024)
- Testing
- ATS 3f Enable Aortic Bioprosthesis Model 6000
- Where
- 10 sites in Austria, Germany and 3 more
- Volunteers
- 173 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
Hypertrophic Cardiomyopathy
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with…
- Trial name
- LIBERTY-HCM (NCT02291237)
- Testing
- Eleclazine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Aortic Valve Stenosis
Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis
The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe…
- Trial name
- RADAR (NCT00538759)
- Testing
- External beam radiation therapy
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Minneapolis Heart Institute Foundation
Healthy Adults (Full Study and Extension Phase), Hypertrophic Cardiomyopathy or Dilated Cardiomyopathy
A Pilot Project Exploring the Impact of Whole Genome Sequencing in Healthcare
The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's whole genome sequence into the practice of clinical medicine.
- Trial name
- NCT01736566
- Testing
- Family History + Whole Genome Sequencing, Family History Only
- Where
- United States
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
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
Cardiomyopathy, Hypertrophic
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
- Trial name
- NCT04164732
- Testing
- LCZ696
- Where
- 18 sites in United States, Germany and 4 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
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
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
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
Coronary Artery Stenoses, Aortic Stenosis
A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced.
- Trial name
- NCT03442400
- Testing
- Volcano iFR/FFR Verrata Plus coronary pressure/flow wire
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- The Cleveland Clinic
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
Ascending Aortic Aneurism, Aortic Valve Insufficiency
Study of Aortic Root Reimplantation Procedure
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
- Trial name
- STAR (NCT01787604)
- Testing
- Aortic Root Reimplantation Procedure, Aortic Valve Reimplantation Procedure
- Where
- Russia
- Volunteers
- 64 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation