Clinical trials: Aortic Valve Disease
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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 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
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
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
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
CoreValve® System Australia/New Zealand Clinical Study
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
- Trial name
- NCT01015612
- Testing
- Medtronic CoreValve® System
- Where
- 10 sites in Australia, New Zealand
- Volunteers
- 634 people
- Sponsor
- Medtronic Cardiovascular
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
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
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
Dental Caries
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.
- Trial name
- NCT01369108
- Testing
- Flowable composite, Conventional composite restorative
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Solventum US LLC
Heart Valve Diseases
Medtronic HAMMOCK Post Approval Study
This study is being conducted to satisfy the post-CE approval requirement.
- Trial name
- NCT03139721
- Testing
- Mosaic model 305, model 310, and ultra model 305
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 122 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Aortic Valve Stenosis
WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement…
- Trial name
- NCT03173534
- Testing
- WATCHMAN, TAVR
- Where
- 32 sites in United States
- Volunteers
- 350 people
- Sponsor
- samir kapadia
Aortic Valve Stenosis
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic…
- Trial name
- NCT00590135
- Testing
- atorvastatin (Lipitor)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Cardiac Disease
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve…
- Trial name
- BAV (NCT01202721)
- Testing
- Atenolol, Telmisartan
- Where
- 13 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Hamilton Health Sciences Corporation
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited