Clinical trials: Diseases of Aortic Valve
Aortic Valve Stenosis
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
- Trial name
- NCT04893603
- Testing
- Transcatheter Aortic Valve System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chengdu Silara Meditech Inc.
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
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
Aortic Valve Stenosis
Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II
Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future…
- Trial name
- SCOPE II (NCT03192813)
- Testing
- Symetis ACURATE neo™ transfemoral TAVI system, Medtronic CoreValve Evolut R TAVI System
- Where
- 23 sites in Denmark, France and 4 more
- Volunteers
- 796 people
- Sponsor
- Ceric Sàrl
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Septal Ablation for Obstructive HCM
Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed.
- Trial name
- NCT06277960
- Testing
- percutaneous intramyocardial septal radiofrequency ablation system
- Where
- China
- Volunteers
- 20 people
- Sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic…
- Trial name
- NCT07230964
- Testing
- Impedance Cardiography Upright/Supine Test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Dermed Diagnostics, Inc.
Cardiomyopathy, Hypertrophic Obstructive
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- LIONHEART-HCM (NCT07755904)
- Testing
- BHB-1893, Metoprolol
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Braveheart Bio, Inc.
Healthy Participants
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05362045
- Testing
- Mavacamten
- Where
- 4 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Aortic Insufficiency
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency
- Trial name
- NCT05424653
- Testing
- Transcatheter Aortic Valve System
- Volunteers
- 10 people
- Sponsor
- Chengdu Silara Meditech Inc.
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
- Trial name
- TTRACK (NCT03842163)
- Testing
- Diagnosis of TTR amyloidosis cardiomyopathy
- Where
- 18 sites in Australia, Austria and 8 more
- Volunteers
- 812 people
- Sponsor
- Pfizer
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Valve Stenosis
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of…
- Trial name
- NCT01514994
- Testing
- AngioScore's Valvuloplasty Scoring Balloon
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease
Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures.
- Trial name
- SOLO-TAVR (NCT07090811)
- Testing
- Aortic valve repair/replacement
- Volunteers
- 20 people
- Sponsor
- Solo Pace, Inc.