Clinical trials: Heart Valve Calcification
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Valve Calcification
Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study
This study seeks to compare aortic dimension changes during cardiac cycle in patients with and without aortic valve calcification and to evaluate its correlation with aortic valve calcium score in former group.
- Trial name
- NCT01755806
- Where
- 3 sites in Iran
- Volunteers
- 104 people
- Sponsor
- Modarres Hospital
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.
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.
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Degenerative Cardiac Valve Disease, Coronary Artery Bypass Surgery Patients
Rate of Microbial Colonization Over Native Calcified Cardiac Valves
The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.
- Trial name
- NCT01409525
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Rambam Health Care Campus
Aortic Valve Stenosis
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic…
- Trial name
- NCT00590135
- Testing
- atorvastatin (Lipitor)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis, Gastrointestinal Microbiome
Involvement of the Gut Microbiota in Calcified Aortic Stenosis
Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation.
- Conditions
- Aortic Stenosis, Gastrointestinal Microbiome, Metabolomics
- Trial name
- Gut-CAS (NCT06021535)
- Testing
- No intervention
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Calcification of Aortic Valve, Aortic Valve Stenosis
Effects of Pioglitazone in Calcific Aortic Valve Disease
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease…
- Trial name
- NCT05875675
- Testing
- Drug: Pioglitazone Oral Tablet
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
Mitral Annular Calcification, Mitral Stenosis
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥…
- Conditions
- Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
- Trial name
- MITRAL-II (NCT04408430)
- Testing
- Transseptal ViMAC
- Where
- 17 sites in United States, Mexico
- Volunteers
- 210 people
- Sponsor
- Mayra Guerrero
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
Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis
This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis.
- Trial name
- NCT02049203
- Testing
- Ataciguat
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Jordan D. Miller, Ph.D.
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 Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
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
Aortic Valve Sclerosis, Aortic Valve Stenosis
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
Aortic stenosis is the most common valvular heart disease and an important public-health problem. Surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using…
- Conditions
- Aortic Valve Sclerosis, Aortic Valve Stenosis, Stenosis Progression, Valvular Heart Disease
- Trial name
- PASP (NCT02241109)
- Testing
- no intervention
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are…
- Trial name
- RACINE (NCT02551588)
- Testing
- Valvular aortic stenosis surgery
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Heart Valve Disease, Aortic Stenosis
Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
Intervention study focused on preventing the progression of aortic valve calcification. Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary…
- Trial name
- CALCIFICA (NCT01000233)
- Testing
- Phytine (phytate)
- Where
- Spain
- Volunteers
- 250 people
- Sponsor
- Hospital Universitari Son Dureta