Clinical trials: Aortic-Stenosis
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Valve Stenosis
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
- Trial name
- VITAL (NCT05977257)
- Testing
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Where
- 4 sites in China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A prospective, multicenter, nonrandomized, single-arm, clinical study.
- Trial name
- NCT03025971
- Testing
- J-Valve Transcatheter Aortic valve replacement
- Where
- 3 sites in China
- Volunteers
- 107 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Valve Disease
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve…
- Trial name
- CENTERA-1 (NCT01808274)
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
- Trial name
- NCT00092677
- Testing
- ezetimibe (+) simvastatin
- Volunteers
- 1,873 people
- Sponsor
- Organon and Co
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Hypertrophic Cardiomyopathy
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Trial name
- NCT06775834
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
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
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Moderate Aortic Valve Stenosis
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
- Trial name
- NCT06650839
- Testing
- NIUT
- Where
- Serbia
- Sponsor
- Cardiawave SA
Hypertrophic Cardiomyopathy
VIZ ACCESS HCM - Multi-Site Registry
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM.
- Trial name
- NCT07103057
- Testing
- Viz HCM
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Viz.ai, Inc.