Clinical trials: Severe Aortic Valve Stenosis, open to volunteers
Severe Aortic Valve Stenosis, Valvular Heart Disease
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis.
- Conditions
- Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
- Trial name
- HYSPANIA (NCT07566624)
- Testing
- Hydra THV
- Where
- 5 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación EPIC
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Aortic Stenosis, Severe, Aortic Valve Stenosis
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used…
- Trial name
- CONTINUUM-CT (NCT06596460)
- Testing
- TAVI planning CT (adapted)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Barts & The London NHS Trust
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
Moderate or Severe Aortic Stenosis
Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
The purpose of this research is to look at an approved intervention (Stethophone application) to obtain additional information about improving detection of moderate or severe aortic stenosis when compared with usual standard of…
- Trial name
- SAGE-AS (NCT07828730)
- Testing
- Stethophone
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
Severe Aortic Stenosis
Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart…
- Trial name
- NCT07813273
- Volunteers
- 122 people
- Sponsor
- Yonsei University
Severe Aortic Stenosis
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis.
- Trial name
- PURETAVI (NCT06898086)
- Testing
- Transcatheter aortic valve implantation
- Where
- 23 sites in Austria, Czechia and 5 more
- Volunteers
- 620 people
- Sponsor
- Rede Optimus Hospitalar SA
Aortic Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
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.
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
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Severe Native Aortic Stenosis
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform
INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor/Navitor Vision Transcatheter Aortic Valve (Navitor/Navitor Vision Valve) in patients with symptomatic, severe native…
- Trial name
- Intensive (NCT07359898)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- IRCCS Policlinico S. Donato
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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 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)
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
Severe Aortic Stenosis
Aspirin vs Clopidogrel After TAVR
Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive…
- Trial name
- NCT05493657
- Testing
- Aspirin single antiplatelet therapy, Clopidogrel single antiplatelet therapy
- Where
- South Korea
- Volunteers
- 270 people
- Sponsor
- Yonsei University
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
Severe Aortic Stenosis
Navitor Japan Study
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
- Trial name
- NCT07193888
- Testing
- Navitor Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital