Clinical trials: Aortic Valve Disorder
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD)
Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative…
- Conditions
- Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative, Neurocognitive Disorders
- Trial name
- HVU-NEURO (NCT07626567)
- Volunteers
- 500 people
- Sponsor
- Heart and Brain Research Group, Germany
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Gingival Recession, Lack of Keratinized Gingiva (Disorder)
Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites
The primary purpose of this protocol is to isolate, investigate and compare the regenerative and differentiation potential of mesenchymal stem cells (MSC's) in the gingival (gum) tissue harvested from two different locations from…
- Trial name
- NCT03570333
- Testing
- progenitor potential of Gingival Mesenchymal cells
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation
- Trial name
- NCT07201363
- Testing
- Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples, Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
- Where
- Croatia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Center Rijeka
Congenital Heart Disease, Aortic Valve Stenosis
Effect of Fetal Aortic Valvuloplasty on Outcomes
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Trial name
- FASSprosp (NCT05386173)
- Testing
- Fetal aortic balloon dilatation
- Where
- 13 sites in United States, Austria and 6 more
- Volunteers
- 200 people
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
Aortic Valve Disease, Aortic Valve Disorder
Trifecta™ GT Post Market Clinical Follow-up
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting.
- Trial name
- NCT03016169
- Testing
- Trifecta GT (Glide Technology) Valve
- Where
- 27 sites in United States, Belgium and 10 more
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves
Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease
Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than…
- Conditions
- Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves, Other Congenital Malformations of Aortic and Mitral Valves, Valvular Heart Disease (Aortic and Mitral Valves)
- Trial name
- NCT05895487
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Coronary Artery Disease, Arrhythmias, Cardiac
Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics
The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear.
- Conditions
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases, Aortic Dissection
- Trial name
- PROSPECT (NCT06001073)
- Testing
- Observational; No Interventions were given.
- Where
- China
- Volunteers
- 25,000 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Aortic Stenosis, Anxiety
10-year Follow-up After Aortic Valve Replacement Surgery
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient…
- Conditions
- Aortic Stenosis, Anxiety, Depressive Symptoms, Quality of Life
- Trial name
- AVR-10year (NCT06255691)
- Volunteers
- 282 people
- Sponsor
- Oslo University Hospital
Aortic Valve Disorder
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very…
- Trial name
- TAVI-LAAC (NCT02678871)
- Testing
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), WATCHMAN
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Stenosis, Severe, Anxiety
Anxiety Reduction in TAVI Using Virtual Reality Trial
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement…
- Trial name
- ART-VR (NCT05069987)
- Testing
- Virtual Reality Immersion
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Erasmus Medical Center
Cognition Disorder
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.
- Trial name
- KogniTa (NCT05464472)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios University Hospital Wuppertal
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Aortic Valve Disorder
Novel Cardiac Imaging Prognostic Markers of Clinical Outcome in Patients With Chronic Aortic Regurgitation
Severe aortic regurgitation is a common valvular heart disease with prevalence of approximately 1%, affecting rather younger patients.
- Trial name
- MOLLI-GLS-Hx (NCT02910349)
- Where
- 5 sites in Belgium, Czechia
- Volunteers
- 129 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Cardiac Arrythmias, Unstable Angina
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking.
- Conditions
- Cardiac Arrythmias, Unstable Angina, Heart Valve Disorders, Disorder of Aorta
- Trial name
- NCT03610529
- Testing
- CardioSenseSystem, Philips Intellivue
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Novosense AB
Severe Aortic Valve Stenosis, Anxiety
Virtual Reality Assisted Conscious Sedation During TAVI
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications.
- Conditions
- Severe Aortic Valve Stenosis, Anxiety, Pain
- Trial name
- TAVI_VR (NCT04259723)
- Testing
- VR during TAVI
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Coronary Artery Disease, Aortic Valve Disorder
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis
- Trial name
- NCT01171625
- Testing
- Implantation of CEP Magna Ease Model 3300TFX
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 283 people
- Sponsor
- Edwards Lifesciences