Clinical trials: Valve Disease, Aortic
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Aortic Stenosis, Diastolic Dysfunction
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD).
- Trial name
- NCT06580158
- Testing
- AI-ECG Dashboard, Point of care ultrasound (POCUS)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Mayo Clinic
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 Stenosis
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
- Trial name
- NCT06749145
- Testing
- Portable 1-lead electrocardiogram, Point-of-care ultrasound, AI-ECG risk algorithm
- Where
- 3 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Yale University
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
Aortic Valve Stenosis
Quality of Care in AS IMPULSE Study
The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated.
- Trial name
- IMPULSE (NCT02241447)
- Where
- 23 sites in Austria, Czechia and 7 more
- Volunteers
- 2,173 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Valvular Heart Disease Patients, Aortic Stenosis
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Trial name
- IMPROVE (NCT07756398)
- Testing
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Where
- 2 sites in United States
- Volunteers
- 1,088 people
- Sponsor
- University of Texas Southwestern Medical Center
Aortic Valve Disease
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A prospective, multicenter, nonrandomized, single-arm, clinical study.
- Trial name
- NCT03025971
- Testing
- J-Valve Transcatheter Aortic valve replacement
- Where
- 3 sites in China
- Volunteers
- 107 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Aortic Valve Disease
PAR I - Patient-to-Annulus Relation I
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome.
- Trial name
- PARI (NCT02981004)
- Where
- 7 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging.
- Trial name
- oHCM (NCT07150299)
- Testing
- Mavacamten in clinical routine use
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
Heart Failure, Valvulopathy
Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients…
- Conditions
- Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease
- Trial name
- OPTIMAV (NCT06667128)
- Testing
- Rapid Uptitration of Guideline-Directed Medical Therapy, Elecsys® NT-proBNP - Roche Diagnostics, Rapid Up-Titration GDMT Group with Hospital Monitoring
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- IRCCS Ospedale San Raffaele
Cardiovascular Diseases
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Bicuspid aortic valve (BAV) is the most common congenital heart anomaly in the general population (1-2% of all individuals). In affected people, the aortic valve (the structure ensuring one way blood flow between the heart's left…
- Trial name
- BRAVE (NCT04514445)
- Testing
- Observational
- Where
- 4 sites in United Kingdom
- Volunteers
- 700 people
- Sponsor
- University Hospitals, Leicester
Bicuspid Aortic Valve (BAV)
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation.
- Trial name
- SUBLIME (NCT06657911)
- Where
- 5 sites in Italy, Switzerland
- Volunteers
- 250 people
- Sponsor
- IRCCS San Raffaele
Heart Valve Diseases
Hemodynamic Performance in Stentless Heart Valves
Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.
- Trial name
- NCT00377871
- Testing
- biological heart valve prosthesis
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- University of Aarhus
Aortic Stenosis, LV Remodeling, Hypertrophy
Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN (NCT01275339)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Coronary Artery Disease, Aortic Valve Disease
Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery.
- Conditions
- Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
- Trial name
- NCT01849757
- Testing
- prime crystalloid, Human Albumin, Voluven
- Where
- Canada
- Sponsor
- University of Saskatchewan
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Lumbar Spinal Stenosis, Cardiac Amyloidosis
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.
- Conditions
- Lumbar Spinal Stenosis, Cardiac Amyloidosis, ATTR Amyloidosis Wild Type, ATTR Gene Mutation
- Trial name
- NCT06034405
- Testing
- Tc99-PYP or Tc99-HDMP Scan
- Where
- 6 sites in United States
- Volunteers
- 1,663 people, healthy volunteers welcome
- Sponsor
- Columbia University
Aortic Stenosis
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).
- Trial name
- PAMIT (NCT02768064)
- Testing
- temporary pacemaker insertion
- Volunteers
- 120 people
- Sponsor
- Hadassah Medical Organization
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