Clinical trials: Aortic Stenosis
Aortic Stenosis
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization…
- Trial name
- DETECT AS (NCT05230225)
- Testing
- Physician Notification Letter
- Where
- United States
- Volunteers
- 940 people
- Sponsor
- Massachusetts General Hospital
Hypertrophic Cardiomyopathy, Myocardial Perfusion Imaging
Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride…
- Trial name
- NCT03150342
- Testing
- myocardial perfusion imaging
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- Far Eastern Memorial Hospital
Severe Symptomatic Aortic Stenosis
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
- Trial name
- NCT02210351
- Testing
- MRI test
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Sheba Medical Center
Aortic Stenosis
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Stenosis; Valve, Renal Failure
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences.
- Conditions
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- Trial name
- NCT04581694
- Testing
- TAVI without contrast
- Where
- Brazil
- Volunteers
- 75 people
- Sponsor
- University of Sao Paulo General Hospital
Aortic Stenosis, Left Ventricle Hypertrophied
Effect of Dapagliflozin on Myocardial and Renal Function Following Aortic Valve Stenosis Intervention
Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.
- Trial name
- DAPAS (NCT05241431)
- Testing
- SGLT2 inhibitor
- Where
- Denmark
- Volunteers
- 106 people
- Sponsor
- University of Aarhus
Aortic Valve Stenosis
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months)…
- Trial name
- Coordinate (NCT03570190)
- Testing
- Coordinator
- Where
- 3 sites in Germany
- Volunteers
- 161 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
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
Severe Aortic Valve Stenosis
MYLEAD Spanish Prospective Registry
Investigator-initiated, prospective, multicentre registry, whose objectives are: 1/ to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year…
- Trial name
- MYLEAD (NCT06917066)
- Testing
- TAVR
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Hospital Clínico Universitario de Valladolid
Critical Aortic Stenosis
The Nordic Aortic Valve Intervention Trial
A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
- Trial name
- NOTION (NCT01057173)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 280 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Valve Stenosis
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis.
- Trial name
- SALVAGE (NCT05696145)
- Volunteers
- 170 people
- Sponsor
- Lisa Gundestrup
Aortic Stenosis
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis.
- Trial name
- ACASA-TAVI (NCT05035277)
- Testing
- Acetylsalicylic acid, Apixaban, Rivaroxaban
- Where
- 3 sites in Norway
- Volunteers
- 360 people
- Sponsor
- Oslo University Hospital
Aortic Stenosis, Severe
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers…
- Trial name
- TRACS (NCT05751577)
- Testing
- TAVI WITHOUT ON-SITE SURGERY, TAVI WITH ON-SITE SURGERY
- Where
- 14 sites in Italy
- Volunteers
- 657 people
- Sponsor
- Azienda Usl di Bologna
Aortic Valve Stenosis
Remote Ischemic Preconditioning in Aortic Valve Surgery
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery.
- Trial name
- RIP-Valve (NCT01390129)
- Testing
- Control, Remote ischemic preconditioning
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Angers
Aortic Valve Stenosis
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe…
- Trial name
- NCT02701283
- Testing
- Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
- Where
- 87 sites in United States, Australia and 5 more
- Volunteers
- 2,223 people
- Sponsor
- Medtronic Cardiovascular
Amyloidosis, Aortic Valve Stenosis
Screening for Amyloidosis Before Aortic Valve Elective Replacement
Previous studies detected that up to 15% of patients undergoing aortic valve replacement (AVR) for degenerative aortic stenosis have concomitant transthyretin amyloidosis (ATTR) cardiomyopathy (Castano, 2017).
- Trial name
- SAVER (NCT04869631)
- Testing
- The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Aortic Aneurysm, Abdominal, Endovascular Procedures
Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries
The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.
- Conditions
- Aortic Aneurysm, Abdominal, Endovascular Procedures, Renal Artery Stenosis
- Trial name
- IFIXEAR (NCT03594786)
- Testing
- endovascular aneurysm repair (EVAR)
- Where
- 2 sites in France
- Volunteers
- 70 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Aortic Valve Stenosis
TAVI in LOW RISK in the REAL WORLD
The primary objective is to assess all-cause mortality, the occurrence of stroke, or rehospitalization for cardiovascular causes in low-risk "all-comers" patients following percutaneous aortic valve replacement
- Trial name
- TAVI IN LOW R (NCT07605780)
- Where
- Italy
- Volunteers
- 650 people
- Sponsor
- Centro Cardiologico Monzino
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