Clinical trials: Aortic Valve Disease
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Aortic Stenosis
transShield Embolic Protection System Feasibility Study
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT04585308
- Testing
- transShield Embolic Protection System
- Where
- 4 sites in New Zealand, Venezuela
- Volunteers
- 28 people
- Sponsor
- TransAortic Medical, Inc.
Severe Symptomatic Aortic Stenosis
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
- Trial name
- NCT04663334
- Testing
- inverse myocardial remodeling
- Where
- France
- Volunteers
- 29 people
- Sponsor
- Nantes University Hospital
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
Severe Aortic Stenosis, TAVI
Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic…
- Trial name
- bTAVI (NCT04286893)
- Testing
- Flow mediated vasodilatation, High resolution ECG, Blood withdrawal
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Cardiac Valve Disease
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and…
- Trial name
- MANTRA (NCT05002543)
- Where
- 52 sites in United States, Austria and 11 more
- Volunteers
- 2,150 people
- Sponsor
- Corcym S.r.l
Aortic Stenosis, Aortic Sclerosis
Risk Factors Associated With Calcification of the Aortic Valve
The purpose of this study is to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(CAD).
- Trial name
- NCT00375336
- Where
- Czechia
- Volunteers
- 300 people
- Sponsor
- Charles University, Czech Republic
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have…
- Trial name
- NCT07807384
- Testing
- Mavacamten
- Volunteers
- 115 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in…
- Trial name
- NCT00504647
- Testing
- Biventricular Pacemaker
- Where
- 3 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University Hospital Birmingham
Aortic Regurgitation
Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.
- Trial name
- NCT05332184
- Testing
- aortic valve surgery
- Volunteers
- 40 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Heart Valve Diseases, Multiple Valve Disease, Unspecified
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves.
- Conditions
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease, Aortic Valve Stenosis
- Trial name
- EACVI-MMVD (NCT06235385)
- Testing
- Intervention not provided
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis, Coronary Artery Disease
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG).
- Trial name
- INCA (NCT03326778)
- Testing
- AVR and CABG
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Campus Bad Neustadt
AORTIC VALVE DISEASES, Calcification; Heart
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification.
- Trial name
- NCT07819344
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Aortic Valve Stenosis
REST Study: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance…
- Trial name
- NCT00256165
- Testing
- Tissue valve
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
Diagnosis of HCM With AI-ECG
The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.
- Trial name
- NCT06287892
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Stenosis, Aortic Valve Failure
Portico Valve-in-Valve Retrospective Registry
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05002088
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
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
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