Clinical trials: Aortic 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
Aortic Valve Stenosis
Impact of Beta Blockers on TAVI (BETA-TAVI)
The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, non-inferiority trial designed to evaluate the safety of continuing versus temporarily interrupting chronic beta-blocker therapy…
- Trial name
- BETA-TAVI (NCT05721170)
- Testing
- Beta blocker
- Where
- 2 sites in Cyprus, Greece
- Volunteers
- 348 people
- Sponsor
- National and Kapodistrian University of Athens
Aortic Valve Stenosis
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking.
- Trial name
- REVALVE (NCT06557798)
- Testing
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Where
- 76 sites in Denmark, Finland and 9 more
- Volunteers
- 550 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
Left Bundle-Branch Block, Aortic Valve Stenosis
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization…
- Trial name
- COME-TAVI (NCT03303612)
- Testing
- Pacemaker implant, Transcutaneous cardiac monitor
- Where
- 10 sites in Canada, France
- Volunteers
- 250 people
- Sponsor
- Montreal Heart Institute
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 Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating…
- Conditions
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TAVR-CT (NCT07107568)
- Testing
- Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy
- Where
- 2 sites in Austria
- Volunteers
- 700 people
- Sponsor
- Medical University Innsbruck
Aortic Stenosis
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
- Trial name
- NCT06749145
- Testing
- Portable 1-lead electrocardiogram, Point-of-care ultrasound, AI-ECG risk algorithm
- Where
- 3 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Yale University
Aortic Valve Stenosis
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- PAPPI (NCT07442357)
- Testing
- Beta-lactam antibiotic with spectrum for Enterococcus faecalis, Cephalosporin
- Where
- 5 sites in Denmark, Sweden
- Volunteers
- 1,986 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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 Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis
Promoting Shared Decision Making for Severe Aortic Stenosis
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: Do patient decision aids and clinician skills training course…
- Trial name
- IMPACT SDM (NCT06171737)
- Testing
- Decision Aid, Shared Decision Making Skills Training
- Where
- 8 sites in United States
- Volunteers
- 1,300 people
- Sponsor
- Massachusetts General Hospital
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body.
- Conditions
- Calcific Aortic Valve Disease, AORTIC VALVE DISEASES, Aortic Valve Stenosis
- Trial name
- VERIFICATION (NCT07715279)
- Testing
- Vericiguat (BAY1021189)
- Where
- China
- Volunteers
- 238 people
- Sponsor
- West China Hospital
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 Stenosis, Structural Valve Deterioration
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical…
- Trial name
- NCT06049654
- Testing
- NVT ALLEGRA TAVI System TF, EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
- Where
- 12 sites in Italy, Spain and 1 more
- Volunteers
- 104 people
- Sponsor
- Fundación EPIC
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement.
- Trial name
- SALTIRE (NCT06047561)
- Testing
- PET-CT
- Where
- United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Valve Stenosis, Aortic Valve Disease
CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter…
- Trial name
- NCT07008911
- Testing
- CardioHeartConnect, CardioHeartEd
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Colorado, Denver
Aortic Stenosis Treated With TAVI, Sedation; Aged; Hemodynamics
High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy.
- Trial name
- NCT07059728
- Testing
- Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2), Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
- Where
- Spain
- Volunteers
- 452 people
- Sponsor
- Hospital Clinic of Barcelona