Clinical trials: Aortic Calcification Valve
Iliac Disease, Aortic Valve Stenosis
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic…
- Trial name
- ILIT (NCT05862558)
- Testing
- Shockwave Balloon
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
Moderate Aortic Valve Stenosis
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
- Trial name
- KATALYST-AV (NCT07001800)
- Testing
- Ataciguat
- Where
- 74 sites in United States, Canada
- Volunteers
- 1,276 people
- Sponsor
- Kardigan, Inc.
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Multidetector Computed Tomography
The Aortic Valve DECalcification (AVADEC) Trial
Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps.
- Conditions
- Aortic Valve Stenosis, Multidetector Computed Tomography, Vitamin K 2, Randomised Clinical Trial
- Trial name
- AVADEC (NCT03243890)
- Testing
- Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
- Where
- Denmark
- Volunteers
- 389 people
- Sponsor
- Axel Diederichsen
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis, AV Block
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in…
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct-pro (NCT03715894)
- Testing
- transcatheter valve implantation
- Where
- 5 sites in Germany, Netherlands and 1 more
- Volunteers
- 300 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Disease, Aortic Valve Stenosis
Myeloid Cells in Aortic Valve Stenosis
Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.
- Trial name
- MIRACLE (NCT04717219)
- Testing
- Blood drawing
- Where
- 3 sites in Netherlands
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
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
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 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.
Aortic Stenosis, Aortic Valve Disease
Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- COMP-AS (NCT06136689)
- Where
- 2 sites in Poland
- Volunteers
- 55 people
- Sponsor
- Medical University of Warsaw
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Aortic Valve Calcification
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated.
- Trial name
- 08-002 (NCT00785109)
- Testing
- Vitamin K supplementation
- Where
- Germany
- Volunteers
- 99 people
- Sponsor
- RWTH Aachen University
Aortic Valve Disease, Valve Heart Disease
Freestyle-Perimount Calcification Comparison
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount…
- Trial name
- NCT04359030
- Testing
- Multislice CT scanning for aortic wall calcification, Transthoracic stress echocardiography
- Where
- Belgium
- Volunteers
- 90 people
- Sponsor
- Ziekenhuis Oost-Limburg
Calcific Aortic Valve Disease, Inflammation
Impact of TAVI on the Gut Microbiota and Its Metabolites
Aortic stenosis is a common heart valve disease in older adults. It occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the rest of the body.
- Conditions
- Calcific Aortic Valve Disease, Inflammation, Dysbiosis, TAVI
- Trial name
- Swiss-GUT-TAVI (NCT07565077)
- Where
- Switzerland
- Volunteers
- 40 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
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 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
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