Clinical trials: Valvular Stenosis
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
- Trial name
- NCT01437098
- Testing
- MDT-2111 CoreValve for TAVI
- Where
- 4 sites in Japan
- Volunteers
- 55 people
- Sponsor
- Medtronic Cardiovascular
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
- 7 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación EPIC
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, Cardiac Conduction Disturbance
Remote Cardiovascular Monitoring in Post-TAVI Patients
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce…
- Conditions
- Aortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health, Transcatheter Aortic Valve Implantation
- Trial name
- TELE-TAVI (NCT06602609)
- Testing
- Remote Patient Monitoring Strategy, Standard Medical Therapy
- Where
- United Kingdom
- Volunteers
- 216 people
- Sponsor
- Imperial College London
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Cardiovascular Diseases
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic…
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-4 (NCT06449469)
- Testing
- Rivaroxaban, Acetylsalicylic acid, Clopidogrel
- Where
- 2 sites in Denmark
- Volunteers
- 352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Valvular Aortic Stenosis
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial…
- Trial name
- NCT00860678
- Testing
- Physical activity, no Intervention
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Technical University of Munich
Aortic Valve Stenosis
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are…
- Trial name
- RACINE (NCT02551588)
- Testing
- Valvular aortic stenosis surgery
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Valvular Heart Disease Stenosis and Regurgitation, Valvular Heart Disease
Screening of Valvular Heart Disease Using Single-channel Electrocardiogram
It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test…
- Trial name
- NCT07099417
- Testing
- No intervention (observational study)
- Where
- Russia
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Valvular Heart Disease, Valvular Stenosis
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of…
- Conditions
- Valvular Heart Disease, Valvular Stenosis, Valvular Insufficiency
- Trial name
- NATURE-VALVE (NCT04509479)
- Testing
- Valve replacement
- Where
- Tunisia
- Volunteers
- 3,637 people
- Sponsor
- Dacima Consulting
Aortic Valve Stenosis
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis
The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient…
- Trial name
- PREFLOW (NCT05580237)
- Testing
- Simultaneous right and left heart catheterization
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Aarhus University Hospital Skejby
Aortic Regurgitation, Mitral Regurgitation
Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.
- Conditions
- Aortic Regurgitation, Mitral Regurgitation, Aortic Stenosis
- Trial name
- NCT06780241
- Testing
- CMR, Quality of Life Questionnaire
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- The Cleveland Clinic
Valvular Stenosis, Valvular Insufficiency
Milrinone Inhaled in Cardiac Surgery
Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC).
- Conditions
- Valvular Stenosis, Valvular Insufficiency, Hypertension, Pulmonary, Coronary Artery Disease
- Trial name
- NCT00819377
- Testing
- Milrinone, Normal saline
- Where
- Canada
- Volunteers
- 124 people
- Sponsor
- Andre Denault
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
Aortic Stenosis
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve.
- Trial name
- NCT01358513
- Where
- United Kingdom
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
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 Valve Stenosis, Mitral Regurgitation
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
- Trial name
- POTUS (NCT05374733)
- Testing
- Coronary Physiology assessment
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Erasmus Medical Center