Clinical trials: Aortic Valve Disease
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Aneurysm Aortic, Aneurysm Aortic Root
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these…
- Trial name
- STORM (NCT07453251)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)
Hypertrophic Obstructive Cardiomyopathy (HOCM) is an inherited cardiac condition which causes the heart muscle to become abnormally thick causing obstruction of blood flow in the heart.
- Trial name
- EMORI-HCM (NCT05257772)
- Testing
- AV Delay Optimised RV Pacing
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
Hypertrophic Obstructive Cardiomyopathy, Thoracic Aortic Dilatation
A Cardiac Disease Quality of Life Study
A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by hypertrophic cardiomyopathy and thoracic aortic dilatations who are not amenable…
- Conditions
- Hypertrophic Obstructive Cardiomyopathy, Thoracic Aortic Dilatation, Heart Disease Caused by Ionising Radiation, Quality of Life
- Trial name
- UPLIFT (NCT04080492)
- Testing
- QOL Survey
- Where
- United States
- Volunteers
- 380 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Cardiomyopathy, Hypertrophic Cardiomyopathies
French Registry: Late Gadolinium Enhancement in Hypertrophic Cardiomyopathy
This study aims to create a registry of patients with hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle. This disease can sometimes lead to serious complications.
- Trial name
- HCM-LGE (NCT07428031)
- Volunteers
- 5,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Stenosis
18F-NaF Uptake and Aortic Stenosis Progression
This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis.
- Trial name
- NCT02740088
- Testing
- Imaging test: 18F-NaF PET/CT
- Volunteers
- 28 people
- Sponsor
- Seoul St. Mary's Hospital
Aortic Valve Stenosis
Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
Over the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic…
- Trial name
- BEST (NCT05454150)
- Testing
- balloon-expandable valve, self-expanding valve
- Where
- 21 sites in France
- Volunteers
- 1,960 people
- Sponsor
- University Hospital, Lille
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 Disease
Podocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease
Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with valvular abnormalities, both stenosis and regurgitation, and aortopathy.
- Trial name
- NCT02806310
- Testing
- Blood draw
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Bassett Healthcare
Aortic Valve Disease
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
- Trial name
- NCT00705913
- Testing
- Mitroflow Aortic Pericardial Heart Valve (CarboMedics), Carpentier-Edwards Magna Tissue Valve
- Where
- 12 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Stenosis
Concentration of Plant Sterols in Serum and Aortic Valve Cusps
This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols.
- Trial name
- NCT00222950
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital, Saarland
Cardiomegaly
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy
The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be…
- Trial name
- NCT01556568
- Testing
- MEK162
- Where
- 2 sites in United States, United Kingdom
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Aortic Valve Disease
Ross for Valve Replacement in AduLts Trial
This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve.
- Trial name
- REVIVAL (NCT03798782)
- Testing
- Ross procedure, Conventional aortic valve replacement
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- Population Health Research Institute
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Coronary Artery Disease., Aortic Valve Stenosis.
Cerebral Oxymetry at Elective Coronary and Valve Surgery.
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.
- Conditions
- Coronary Artery Disease., Aortic Valve Stenosis., Aortic Valve Regurgitation.
- Trial name
- Co-HLM (NCT01940874)
- Where
- Norway
- Volunteers
- 54 people
- Sponsor
- Oslo University Hospital
Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy…
- Trial name
- CT-CA (NCT03291925)
- Testing
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
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
Ethics, Cardiac Rehabilitation
The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance
Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.
- Conditions
- Ethics, Cardiac Rehabilitation, Coronary Heart Disease (CHD), Heart Failure
- Trial name
- MOST-CR (NCT07123480)
- Testing
- Usual Care Group, More Support and Tools
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Baystate Medical Center
Iron Deficiencies, Calcified Aortic Valve
ID as a Promoter of IH-induced CAVD
Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms.
- Trial name
- NCT06200870
- Volunteers
- 3,000 people
- Sponsor
- Qilu Hospital of Shandong University
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