Clinical trials: Diseases of Aortic Valve
Cardiac Valve Disease, Aortic Valve Disease
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time.
- Conditions
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
- Trial name
- NCT06001489
- Testing
- 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory, Amsterdam Preoperative Anxiety and Information Scale
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL).
- Trial name
- REDOX-TAVI (NCT04171726)
- Testing
- Edoxaban
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis, Heart Failure
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
- Conditions
- Aortic Stenosis, Heart Failure, Syncope, Angina Pectoris
- Trial name
- TASS-2 (NCT02448485)
- Testing
- Aortic Valve Intervention (surgical or transcatheter)
- Where
- Austria
- Volunteers
- 10,000 people
- Sponsor
- Medical University Innsbruck
Hypertrophic Cardiomyopathy
Family Studies of Inherited Heart Disease
Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle.
- Trial name
- NCT00001225
- Where
- United States
- Volunteers
- 5,880 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis, Bicuspid Cardiac Valve
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
- Trial name
- PRECISE_TAVI (NCT04473443)
- Testing
- FEops HEARTguideTM
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Cardiac Surgery, Coronary Artery Disease
Enhanced Recovery After Cardiac Surgery
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide.
- Conditions
- Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
- Trial name
- ERAS (NCT03859102)
- Testing
- Pre-operative Carbohydrate PreLoad drink, Oral Gabapentin pre-op, Oral Lansoprazole pre-op
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- James Cook University Hospital
Aortic Valve Disease, Transcatheter Aortic Valve Replacement
The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures
TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Hemodynamic Measurement
- Trial name
- SAVVY (NCT05082337)
- Testing
- SAVVY guidewire
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Atrial Fibrillation, Hypertrophic Cardiomyopathy
HCM-AF Ablation With ACUTUS
BACKGROUND About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span.
- Trial name
- NCT04090437
- Testing
- Catheter ablation procedure
- Volunteers
- 20 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Heart Failure, Excessive Amount of Blood / Fluid Transfusion
Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable.
- Conditions
- Heart Failure, Excessive Amount of Blood / Fluid Transfusion, Intraoperative Cardiac Arrest During Cardiac Surgery, Critical Incident
- Trial name
- AVIATOR (NCT01390675)
- Where
- Germany
- Volunteers
- 10,000 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise.
- Trial name
- AS-BNP (NCT00567437)
- Testing
- NT-pro-BNP levels
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Duke University
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
Cardiac Arrest, Transcatheter Aortic Valve Implantation
The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation
This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation
- Trial name
- NCT04687202
- Testing
- follow up and record
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Type II Diabetes
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
- Trial name
- DIAPASON (NCT01862237)
- Testing
- Intervention
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück
Aortic Valve Disease
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution.
- Trial name
- RVAOMITAVA (NCT04455165)
- Testing
- Aortic valve replacement
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Centre Hospitalier La Chartreuse
Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome
Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank
The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD).
- Conditions
- Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), Long QT Syndrome (LQTS)
- Trial name
- HiRO (NCT04189822)
- Where
- Canada
- Volunteers
- 10,000 people
- Sponsor
- University of British Columbia
Valvular Heart Disease
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
- Trial name
- EPIC (NCT00329667)
- Testing
- EPIC
- Volunteers
- 761 people
- Sponsor
- Abbott Medical Devices
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