Clinical trials: Valve Disease, Aortic
Valvular Heart Disease
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the…
- Trial name
- NCT03797820
- Testing
- Our study type is observational
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Valve Stenosis, Aortic Valve Insufficiency
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a prospective Italian registry including several centers performing TAVI, collecting baseline, procedural and outcome data.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement
- Trial name
- NCT02713932
- Testing
- Transcatheter aortic valve implantation
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM.
- Trial name
- NCT05174416
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 81 people
- Sponsor
- LianBio LLC
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Stenosis
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
- Trial name
- TAVR-CMR (NCT03831087)
- Testing
- TAVR-CMR, TAVR-CT
- Where
- Austria
- Volunteers
- 267 people
- Sponsor
- Medical University Innsbruck
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Aortic Stenosis
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize…
- Trial name
- SCRABLES (NCT02856620)
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Christine Henri
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
Aortic Valve Stenosis
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis.
- Trial name
- CAVS (NCT02481258)
- Testing
- Ataciguat (HMR1766)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Aortic Stenosis
Role of Elastin Metabolites in Aortic Remodelling in AS
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age.
- Trial name
- ELASTIC-AS (NCT03883490)
- Testing
- ECG, Blood test and biobanking, Trans-thoracic Echocardiogram
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- University of Leicester
Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve
Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve.
- Trial name
- NCT04756778
- Testing
- Aortic surgery +/- aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- St. George's Hospital, London
Tricuspid Regurgitation
Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid…
- Trial name
- HOVER (NCT02339974)
- Testing
- Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Henry Ford Health System
Transcatheter Aortic Valve Replacement
TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut…
- Trial name
- NCT04517955
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 5 sites in Greece
- Volunteers
- 80 people
- Sponsor
- University of Athens
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable I Long-term Follow-up Study
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous…
- Trial name
- NCT01636648
- Testing
- Aortic Valve Replacement
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 42 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Valvular Aortic Stenosis
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial…
- Trial name
- NCT00860678
- Testing
- Physical activity, no Intervention
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Technical University of Munich
Aortic Stenosis
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Aortic stenosis (AS) affects approximately 5% of individuals >65 years old, with ~3% of people >75 years having moderate to severe disease.
- Trial name
- EASY-AS (NCT04204915)
- Testing
- Aortic valve replacement
- Where
- 110 sites in Australia, Belgium and 5 more
- Volunteers
- 2,104 people
- Sponsor
- University of Leicester
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
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
Aortic Stenosis
TAVR Without Predilatation
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon…
- Trial name
- TAVIWOP (NCT04350658)
- Testing
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Where
- France
- Volunteers
- 138 people
- Sponsor
- University Hospital, Montpellier
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