Clinical trials: Aortic Valve
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
Effects of Rosuvastatin on Aortic Stenosis Progression
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis.
- Trial name
- ASTRONOMER (NCT00800800)
- Testing
- Rosuvastatin
- Where
- 15 sites in Canada
- Volunteers
- 378 people
- Sponsor
- AstraZeneca
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
- Trial name
- NCT02523066
- Testing
- Magna Ease
- Where
- China
- Volunteers
- 215 people
- Sponsor
- Edwards Lifesciences
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
Severe Aortic Valve Stenosis
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
- Trial name
- NCT04988243
- Testing
- All aortic valve products on the market
- Volunteers
- 320 people
- Sponsor
- CCRF Inc., Beijing, China
Aortic Valve Replacement
RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and…
- Trial name
- RESILIENCE (NCT03680040)
- Testing
- Subjects previously implanted with a RESILIA aortic tissue valve.
- Where
- 10 sites in United States
- Volunteers
- 110 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis Symptomatic
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- TA-FIM (NCT03567278)
- Testing
- ACURATE TA™
- Where
- 5 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Symetis SA
Aortic Stenosis
Vivio AS (Aortic Stenosis) Detection Study
Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.
- Trial name
- NCT04066634
- Testing
- Vivio System
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Heart Diseases
Carotid Filtration During Endovascular Aortic Valve Implantation
This study was designed as a First In Man (FIM) trial to evaluate the feasibility and technical capability of the Claret CE Pro System in delivering two embolic filters to the brachiocephalic artery and the left common carotid…
- Trial name
- NCT01484249
- Testing
- CE Pro System
- Volunteers
- 38 people
- Sponsor
- Claret Medical
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
Aortic Valve Stenosis
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- NCT02209298
- Testing
- CoreValve Transcatheter Valve
- Where
- 25 sites in France, Germany and 2 more
- Volunteers
- 202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Stenosis
Sorin Universal REgistry on Aortic Valve Replacement
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide.
- Trial name
- SURE-AVR (NCT02679404)
- Where
- 52 sites in United States, Australia and 15 more
- Volunteers
- 2,758 people
- Sponsor
- Corcym S.r.l
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 Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Aortic Stenosis
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
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
Aortic Valve Stenosis
A Study to Evaluate the Neuro-embolic Consequences of TAVR
A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT02073864
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Keystone Heart
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