Clinical trials: Aortic Valve Insufficiency, open to volunteers
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
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 34 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
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
Aortic Regurgitation, Aortic Valve Insufficiency
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ART (NCT07453407)
- Testing
- J-VALVE Transfemoral Aortic Valve system, Commercially available surgical biological aortic valve replacement device
- Where
- 28 sites in China
- Volunteers
- 1,250 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
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
Mitral Insufficiency, Transcatheter Aortic Valve Replacement
Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study
Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases.
- Trial name
- TEMATIC-MR (NCT07370467)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Centro Cardiologico Monzino
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
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
J-Valve Transfemoral Pivotal Study
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed…
- Trial name
- JOURNEY (NCT06455787)
- Testing
- J-Valve Transfemoral (TF) System
- Where
- 40 sites in United States, Canada and 3 more
- Volunteers
- 194 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
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
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