Clinical trials: Aortic Stenosis, Severe, open to volunteers
Severe Aortic Valve Stenosis
ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
Title: The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves Brief Summary: The goal of this clinical trial is to compare the latest-generation balloon-expandable…
- Trial name
- TAVR (NCT07545369)
- Testing
- SAPIEN 3 Ultra Resilia, Evolut FX
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Assiut University
Aortic Valve Stenosis
OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY
In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of…
- Trial name
- OUTSTANDING (NCT05778773)
- Testing
- TAVR (Transcatheter Aortic Valve Replacement), AVR (Aortic Valve Replacement)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- IRCCS Policlinico S. Donato
Severe Aortic Stenosis
A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).
PAVI-TAVI Registry Overview The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy.
- Trial name
- PAVI_TAVI (NCT07596394)
- Testing
- Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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.
Aortic Stenosis
A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis
- Trial name
- NCT05673525
- Testing
- Transcatheter Aortic Valve Implantation (KOKA-VALVE)
- Where
- China
- Volunteers
- 131 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Valve Stenosis
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone…
- Trial name
- NCT07335900
- Testing
- Transcatheter Aortic Valve Implantation, Optimal medication treatment
- Where
- China
- Volunteers
- 25 people
- Sponsor
- RenJi Hospital
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Severe Aortic Valve Stenosis
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
- Trial name
- NCT04988243
- Testing
- All aortic valve products on the market
- Volunteers
- 320 people
- Sponsor
- CCRF Inc., Beijing, China
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Reversibility of Cardiac Conduction Disturbances Following TAVI
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
- Trial name
- TAVI-REVERSE (NCT06481137)
- Testing
- Electrophysiological study (EP study), ePatch (extended Holter Monitoring)
- Where
- Spain
- Volunteers
- 209 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Aortic Stenosis, Severe
Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations.
- Trial name
- SELECT TAVR (NCT07689279)
- Testing
- Transcatheter Heart Valve
- Volunteers
- 604 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy
Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR)
This is a multicenter, prospective, open-label, randomized, investigator-initiated trial evaluating whether angiotensin receptor blocker (ARB) therapy improves clinical outcomes in patients with severe aortic stenosis (AS) and…
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy, Severe Aortic Stenosis
- Trial name
- ARBITAR (NCT07735130)
- Testing
- Angiotensin Receptor Blocker (ARB)
- Where
- South Korea
- Volunteers
- 632 people
- Sponsor
- Seoul National University Hospital
Aortic Valve Stenosis
Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
This is a prospective, multicenter, randomized controlled clinical study designed to evaluate the real-world performance of the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System…
- Trial name
- Flex-TAVR (NCT07145463)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis, Severe Aortic Stenosis
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes.
- Trial name
- ATLAS (NCT06818006)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight, Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
- Where
- 2 sites in Canada
- Volunteers
- 600 people
- Sponsor
- University of Alberta
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Cardiomyopathies, Amyloidosis Cardiac
Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation
The study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging…
- Conditions
- Cardiomyopathies, Amyloidosis Cardiac, Fabry Disease, Arrhythmogenic Cardiomyopathy
- Trial name
- CMPMIRNA (NCT06813443)
- Where
- 3 sites in Italy
- Volunteers
- 700 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Severe Aortic Stenosis
Act on Quality of Life in Patients With aortIc Stenosis
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions.
- Trial name
- ALPINIST (NCT06477042)
- Testing
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
- Where
- 4 sites in France
- Volunteers
- 240 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native…
- Trial name
- LANDMARK (NCT04275726)
- Testing
- Myval THV Series, Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Where
- 54 sites in Belarus, Brazil and 15 more
- Volunteers
- 988 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.