Clinical trials: Aortic Regurgitation
Aortic Valve Insufficiency, Aortic Aneurysm
HAART Annuloplasty Device Valve Repair Registry
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice…
- Trial name
- NCT04035356
- Testing
- Aortic valve repair
- Where
- 5 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biostable Science & Engineering
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
Bicuspid Aortic Valve (BAV), Aortic Regurgitation Disease
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure.
- Trial name
- CONTOUR (NCT06869954)
- Testing
- Internal HAART 200 annuloplasty device, double external ring annuloplasty
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital Augsburg
Aortic Valve Stenosis, Aortic Valve Insufficiency
Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry
In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Ventricular Outflow Obstruction, Left
- Trial name
- NCT03361046
- Testing
- Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
- Where
- 12 sites in Poland
- Volunteers
- 150 people
- Sponsor
- Medical University of Warsaw
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 Regurgitation
Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome
This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation
- Trial name
- NCT07104968
- Where
- Sweden
- Volunteers
- 35,000 people
- Sponsor
- Uppsala University
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
Mitral Valve Insufficiency, Aortic Valve Insufficiency
Effect of Anesthetics on Troponin I and С-reactive Protein
Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and…
- Conditions
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Cardiac Disease
- Trial name
- NCT05742789
- Testing
- Propofol, Isoflurane, Sevoflurane
- Where
- Kazakhstan
- Volunteers
- 255 people
- Sponsor
- Astana Medical University
Paravalvular Leak
Cardiac MRI for Post-TAVR Paravalvular Leak Assessment
The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with…
- Trial name
- Class-CMR (NCT03195114)
- Testing
- Multimodality Imaging and Biomarkers
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- University of Pittsburgh
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
Valvular Heart Disease
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the…
- Trial name
- PREVUE-VALVE (NCT05357404)
- Where
- United States
- Volunteers
- 2,870 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research Foundation, New York
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
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
Heart Valve Diseases, Aortic Valve Insufficiency
Transpacific TAVR Registry
This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.
- Trial name
- TP-TAVR (NCT03826264)
- Testing
- TAVR
- Where
- 7 sites in United States, China and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Duk-Woo Park, MD
Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation
ECG and CXR for Predicting Cardiovascular Diseases
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular…
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Trial name
- NCT07573852
- Where
- China
- Volunteers
- 116,380 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Pure Aortic Regurgitation
Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation
The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.
- Trial name
- S3AR (NCT04671758)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Disease, Aortic Valve Insufficiency
J-Valve Compassionate Use
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
- Conditions
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- NCT03876964
- Testing
- Transcatheter Aortic Valve Replacement
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC