Clinical trials: Heart Valvular Disease
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Heart Valve Diseases
Cardiovascular Acoustics and an Intelligent Stethoscope
The aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage.
- Trial name
- CAIS (NCT04445012)
- Where
- 5 sites in United Kingdom
- Volunteers
- 1,150 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
Valve Heart Disease, Coronary Artery Disease
Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019.
- Conditions
- Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease, Aortic Diseases
- Trial name
- NCT07662317
- Testing
- Cardiac surgey
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 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 Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Stenosis, Gut Microbiome
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis.
- Conditions
- Aortic Stenosis, Gut Microbiome, Gut Microbiota, TAVI
- Trial name
- GUT-TAVI (NCT07052071)
- Testing
- TAVI
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Hippocration General Hospital
Aortic Regurgitation
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.
To investigate the performance of currently available THVs in terms of safety and efficacy To evaluate potential predictors of THV embolization or migration (TVEM) To assess the impact of TVEM on prognosis
- Trial name
- PANTHEON (NCT05319171)
- Testing
- TAVR
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Valve Stenosis, Aortic Stenosis
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
- Trial name
- NCT04056832
- Testing
- Single Strip Pericardium, Mechanical Prosthetic Valve
- Where
- Indonesia
- Volunteers
- 62 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Congenital Heart Disease, Bicuspid Aortic Valve
Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve
Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the heart to the body) are not formed right.
- Trial name
- NCT00412386
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Emory University
Aortic Stenosis
Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
- Trial name
- NCT03557242
- Testing
- TAVR, Warfarin plus Aspirin, Aspirin Only
- Where
- 7 sites in United States
- Volunteers
- 124 people
- Sponsor
- Medstar Health Research Institute
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Cardiomyopathy, Hypertrophic, Familial
Signs and Symptoms of Genetic Abnormalities Linked to Inherited Heart Disease
Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information.
- Trial name
- NCT00001881
- Where
- United States
- Volunteers
- 9,999 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Valve Stenosis, Malignancy
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk.
- Trial name
- TOP-AS (NCT03181997)
- Testing
- Native aortic valve, Transcatheter aortic valve implantation (TAVI)
- Where
- Israel
- Volunteers
- 168 people
- Sponsor
- Rabin Medical Center
Aortic Stenosis, Trans-catheter Aortic Valve Implantation
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve…
- Conditions
- Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Commissural Alignment
- Trial name
- ALIGN-EFX (NCT07217691)
- Testing
- Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25, Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.
- Volunteers
- 40 people
- Sponsor
- Oslo University Hospital
Heart Valve Disease
On-X Heart Valve - 17mm Aortic and 23mm Mitral
This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.
- Trial name
- NCT01812174
- Testing
- 17mm aortic valve (On-X ), 23mm mitral valve (On-X)
- Where
- 10 sites in United States, Puerto Rico and 1 more
- Volunteers
- 20 people
- Sponsor
- On-X Life Technologies, Inc.
Hypertrophic Cardiomyopathy
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults.
- Trial name
- NCT00001396
- Testing
- Paragon Pacemaker
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Atrial Fibrillation, Thrombosis
Association of Genetic Polymorphisms With Atrial Fibrosis and Thrombogenic Substrate in Patients With Non-valvular Atrial Fibrillation
Atrial fibrillation (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF.
- Conditions
- Atrial Fibrillation, Thrombosis, Stroke, Genetic Predisposition
- Trial name
- ANATOLI-AF (NCT03560219)
- Testing
- Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis
- Volunteers
- 225 people
- Sponsor
- Memorial Ankara Hospital