Clinical trials: Valve Disease, Aortic
Severe Aortic Valve Stenosis
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient…
- Trial name
- VRAP-Heart (NCT05552352)
- Testing
- Virtual Reality assisted information
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Myocardial Diseases, Perfusion Imaging
Validation of Myocardial Perfusion and Extracellular Volume Assessment Using Photon-Counting Computed Tomography (PCCT) Compared With Cardiac Magnetic Resonance (CMR) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Cardiovascular diseases are the leading cause of death worldwide, responsible for about 30% of all deaths. This substantial burden highlights the need for accurate diagnostic tools that help doctors detect heart disease early and…
- Conditions
- Myocardial Diseases, Perfusion Imaging, Stress Perfusion, Myocardial Fibrosis
- Trial name
- NCT07799363
- Testing
- Stress myocardial perfusion imaging with PCCT. Extracellular volume quantification with PCCT.
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska University Hospital
Severe Aortic Valve Stenosis, High-degree AV Block
Infranodal Conduction Time During TAVR as Predictor of HAVB
Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker…
- Conditions
- Severe Aortic Valve Stenosis, High-degree AV Block, Left Bundle-Branch Block
- Trial name
- HOM-TAVI (NCT04128384)
- Testing
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital, Saarland
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025.
- Trial name
- CHATEAU (NCT07709858)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- South Korea
- Volunteers
- 4,000 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Aortic Stenosis, Gender
TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over…
- Conditions
- Aortic Stenosis, Gender, Surgery
- Trial name
- NCT04915976
- Volunteers
- 14,086 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
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
Heart Diseases, Mitral Valve Stenosis
Balloon Valvuloplasty Registry
To establish a registry in order to collect and analyze baseline and outcome data on patients with severe valvular stenosis treated with balloon valvuloplasty.
- Conditions
- Heart Diseases, Mitral Valve Stenosis, Aortic Valve Stenosis
- Trial name
- NCT00005199
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis, Heart Valve Diseases
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible.
- Trial name
- NCT02272621
- Testing
- Minimally invasive aortic valve replacement, Full sternotomy aortic valve replacement
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska University Hospital
Aortic Stenosis
CMR-AI and Outcomes in AS
Background \& Aims: Artificial Intelligence (AI) in cardiac magnetic resonance (CMR) imaging has previously been shown to provide highly reproducible and accurate measures of myocardial structure and function, outperforming…
- Trial name
- NCT06128876
- Where
- 7 sites in Austria, Belgium and 4 more
- Volunteers
- 1,500 people
- Sponsor
- Medical University of Vienna
Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation)
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation).
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Trial name
- CROS-TAVI (NCT07016789)
- Testing
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Amyloidosis Cardiac, Aortic Stenosis, Severe
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree.
- Trial name
- CAUSATIVE (NCT06066632)
- Where
- Italy
- Volunteers
- 480 people
- Sponsor
- University Hospital of Ferrara
Aortic Stenosis
The Plasma Serotonin and Aortic Stenosis: a Pilot Study.
The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac muscle.
- Trial name
- SERAOPI (NCT02833090)
- Testing
- biomarkers
- Where
- France
- Volunteers
- 52 people
- Sponsor
- University Hospital, Toulouse
Hypertrophic Cardiomyopathy (HCM)
One-stop Evaluation of Hypertrophic Cardiomyopathy in Cardiac Magnetic Resonance
This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients.
- Trial name
- NCT07336290
- Volunteers
- 10,000 people
- Sponsor
- Minjie Lu
Aortic Valve Stenosis, Aortic Valve Surgery
Early Surgery for Patients With Asymptomatic Aortic Stenosis
Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field…
- Trial name
- ESTIMATE (NCT02627391)
- Testing
- Early surgical aortic valve replacement, Delayed Surgical aortic valve replacement
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypertrophic Cardiomyopathy
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
- Trial name
- NCT04112290
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Mayo Clinic
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Pelvic Organ Prolapse
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).
- Trial name
- NCT01749696
- Where
- Finland
- Volunteers
- 78 people
- Sponsor
- Turku University Hospital
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.
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