Clinical trials: Aortic Valve Stenosis and Insufficiency, active
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018.
- Conditions
- Coronary Artery Disease, Arterial Stiffness, Blood Pressure, AORTIC VALVE DISEASES, Mitral Valve Stenosis and/or Insufficiency
- Trial name
- SCAPIS-ReEx (NCT07476703)
- Testing
- Coronary computer tomography (CCTA), Echocardiograhy and aortic ultrasound, Liver elastography
- Where
- Sweden
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Danderyd Hospital
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
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 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
Valvular Heart Disease
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR).
- Trial name
- HOMERUNHITTER (NCT06077201)
- Testing
- HBCR hands-off, HBCR interactive
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Vanderbilt University Medical Center
Valvular Heart Disease Patients, Aortic Stenosis
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Trial name
- IMPROVE (NCT07756398)
- Testing
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Where
- 2 sites in United States
- Volunteers
- 1,088 people
- Sponsor
- University of Texas Southwestern Medical Center
Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease
- Trial name
- RESOUND-EU (NCT06953206)
- Testing
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Aortic Valve Stenosis, Chronic Kidney Diseases
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute Chronic
- Trial name
- TAVIKOD (NCT07626710)
- Testing
- Trans-catheter aortic valve implantation (TAVI)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Stenosis, Mitral Regurgitation
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- MASTER-TAVI II (NCT07623083)
- Volunteers
- 300 people
- Sponsor
- Josep Rodes-Cabau
Aortic Stenosis, Aortic Regurgitation
Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT07605624
- Testing
- Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty
- Where
- China
- Volunteers
- 5,500 people
- Sponsor
- Beijing Anzhen Hospital
Aortic Valve Stenosis, Aortic Valve Insufficiency
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality.
- Trial name
- WITAVI-REAL (NCT03728049)
- Testing
- CT-ADP performed during TAVI procedure, No CT-ADP performed during TAVI procedure
- Where
- 9 sites in France
- Volunteers
- 944 people
- Sponsor
- University Hospital, Lille
Aortic Valve Disease, Aortic Aneurysm
Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)
Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body…
- Trial name
- ARTIK (NCT06286358)
- Testing
- Kinocardiography
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Université Libre de Bruxelles
Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting…
- Trial name
- Echo Prompts (NCT06816888)
- Testing
- No Prompt, Prompt 1, Prompt 2
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Sleep-disordered Breathing (SDB), Aortic Valve Stenosis
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients…
- Conditions
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- Trial name
- SLEEP-VALVE (NCT07520656)
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Aristides Plaitis
Degenerative Aortic Valve Disease, Aortic Stenosis
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS)…
- Conditions
- Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03383445
- Testing
- Edwards, CoreValve, Acurate neo
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec