Clinical trials: Calcified Aortic Valve
Aortic Valve Disease
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk.
- Trial name
- NCT03163329
- Testing
- TAVR, SAVR
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis, Calcific
Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism…
- Trial name
- FIB-AS (NCT03585933)
- Testing
- Cardiac magnetic resonance imaging
- Where
- 2 sites in Denmark, Lithuania
- Volunteers
- 110 people
- Sponsor
- Vilnius University
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Symptomatic Aortic Stenosis
Image Fusion and Calcification Raising in Trans Aortic Valve Implantation
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve implantation (TAVI) has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk…
- Trial name
- TAVI (NCT03247465)
- Testing
- Image Fusion
- Where
- France
- Sponsor
- Nantes University Hospital
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Calcific
PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- PICASO (NCT07256197)
- Testing
- Treatment with PCSK9 inhibitors, Treatment without PCSK9 inhibitors
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Calcified Aortic Valve
A Prospective RegistrY of Cardiac Echographic Loops
CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e.
- Trial name
- ARYEL (NCT03371524)
- Testing
- Cardiac Echography
- Where
- 3 sites in France
- Volunteers
- 90 people
- Sponsor
- Cardiawave SA
Aortic Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Vascular Calcification, Chronic Kidney Diseases
a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.
- Trial name
- NCT03858413
- Testing
- No intervention
- Volunteers
- 60 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Hypertension, Aortic Stenosis, Calcific
Pressure Assessment to Improve Outcomes After TAVR: a Registry
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures.
- Conditions
- Hypertension, Aortic Stenosis, Calcific, Quality of Life, Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT03923530
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- North Florida Foundation for Research and Education
Heart Disease
4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure.
- Trial name
- C4CAPRI (NCT02935491)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- France
- Volunteers
- 1,600 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Aortic Stenosis, Imaging
Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study
Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the…
- Conditions
- Aortic Stenosis, Imaging, Pathogenesis, Disease Progression
- Trial name
- NCT05851209
- Where
- 3 sites in Germany
- Volunteers
- 938 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Calcific Aortic Valve Disease
Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD
This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.
- Trial name
- DIP-CAVD (NCT04055883)
- Testing
- DA-1229
- Where
- 10 sites in South Korea
- Volunteers
- 228 people
- Sponsor
- Dong-A ST Co., Ltd.
Aortic Stenosis
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- SAINT-TAVR Ca (NCT06722066)
- Testing
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Eunpyeong St. Mary's Hospital