Clinical trials: Stenoses, Aortic
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
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, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Trial name
- NCT04414865
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
Aortic Stenosis Symptomatic
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- 2011-03 (NCT03752996)
- Testing
- ACURATE TF™ Aortic Valve System
- Where
- 5 sites in Brazil, Germany
- Volunteers
- 140 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis, Severe
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic…
- Trial name
- NCT05989074
- Testing
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- Volunteers
- 130 people
- Sponsor
- Ceric Sàrl
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
Aortic Valve Stenosis, Severe Aortic Stenosis
A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native…
- Trial name
- CREATE (NCT07734025)
- Testing
- Investigational Transcatheter Aortic Valve Replacement System
- Volunteers
- 30 people
- Sponsor
- Onecrea Medical Inc.
Aortic Valve Stenosis
Hydra Registry - UK
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the…
- Trial name
- NCT06507579
- Testing
- Hydra transcatheter aortic valve (THV) series
- Where
- 4 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Sahajanand Medical Technologies Limited
Severe Aortic Stenosis
CoreValve Advance International Post Market Study
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
- Trial name
- NCT01074658
- Testing
- Medtronic CoreValve System
- Where
- 44 sites in Belgium, Colombia and 10 more
- Volunteers
- 1,015 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Cancer
An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).
- Trial name
- NCT01077830
- Volunteers
- 1,392 people
- Sponsor
- Organon and Co
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
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
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT04770142
- Testing
- TIRA catheter
- Where
- 9 sites in South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU 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 symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
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
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.