Clinical trials: Aortic Stenosis Disease
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Stenosis
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
- Trial name
- TAVI (NCT02070731)
- Testing
- TriGuard HDH
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 86 people
- Sponsor
- Keystone Heart
Obstructive Hypertrophic Cardiomyopathy
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).
- Trial name
- CAMELLIA-HCM (NCT07023341)
- Testing
- BAY3723113
- Where
- 23 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Bayer
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Diseases of Aortic Valve, Aortic Stenosis Disease
Clinical Trial in China for Aortic Valve Stenosis
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
- Trial name
- NCT05607667
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 15 people
- Sponsor
- Genesis Medtech Corporation
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- RADIANT (NCT02799823)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- HLT Inc.
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Aortic Stenosis
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
- NCT05893082
- Testing
- F2 Filter and Delivery System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Valve Stenosis, Aortic Valve Failure
Portico and Navitor India Clinical Trial
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05171712
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Cardiomyopathy, Hypertrophic Obstructive
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic…
- Trial name
- HORIZON-HCM (NCT05414175)
- Testing
- Mavacamten
- Where
- 20 sites in Japan
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Aortic Valve Stenosis
VitaFlow™ 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™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
- Trial name
- NCT07107373
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
- Trial name
- SEQUOIA-HCM (NCT05186818)
- Testing
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)
- Where
- 114 sites in United States, China and 12 more
- Volunteers
- 282 people
- Sponsor
- Cytokinetics
Hypertrophic Cardiomyopathy
A Trial of HS-10511 in Healthy Subjects
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single…
- Trial name
- NCT06210607
- Testing
- HS-10511 Tablets
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices