Clinical trials: Aortic-Stenosis
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
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 Stenosis
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
- Trial name
- TALP-FIM (NCT02986737)
- Testing
- ACURATE neo™ and ACURATE TA™ LP
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Symetis SA
Moderate Aortic Valve Stenosis
Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.
- Trial name
- NCT07060183
- Testing
- Ross procedure
- Sponsor
- Dermed Diagnostics, Inc.
Stenoses, Aortic Valve
REPRISE China - Clinical Evaluation in China
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high…
- Trial name
- NCT03084510
- Testing
- Lotus Edge™ Valve System
- Where
- China
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Hypertrophic Cardiomyopathy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02329184
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- MyoKardia, Inc.
Aortic Stenosis
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the…
- Trial name
- SAVI TF (NCT02306226)
- Volunteers
- 1,000 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York…
- Trial name
- MEMENTO (NCT06112743)
- Testing
- Mavacamten
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic…
- Trial name
- PORTICO-IDE (NCT02000115)
- Testing
- Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
- Where
- 70 sites in United States, Australia
- Volunteers
- 1,242 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Post-Market Clinical Follow Up Study With Navitor Valve
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
- Trial name
- VISTA Nova (NCT06008080)
- Testing
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Where
- 50 sites in Australia, France and 9 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
U.S. Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT06069661
- Testing
- Aortic Stenosis
- Where
- United States
- Sponsor
- EnCompass Technologies, Inc.
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Aortic Valve Stenosis
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Trial name
- NCT02073851
- Testing
- TriGuard™HDH
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Keystone Heart