Clinical trials: Aortic Stenosis
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis
Prospective Balloon Aortic Valvuloplasty
The primary objective of this study is to determine the reasons for balloon aortic valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in patients with aortic stenosis.
- Trial name
- BAV (NCT02122900)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis, Hypertension
Transcatheter Aortic Valve Implantation in Western NORway
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.
- Trial name
- TAVI-NOR (NCT04417829)
- Testing
- Biological prosthesis in the aortic valve
- Volunteers
- 600 people
- Sponsor
- Haukeland University Hospital
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Conduction Disturbances
Systematic Ambulatory ECG Monitoring Following TAVI
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of…
- Trial name
- RECORDII (NCT07739316)
- Testing
- Ambulatory ECG monitoring
- Where
- Canada
- Volunteers
- 754 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)
Ilioinguinal and iliohypogastric (ILIH) nerve blocks are frequently performed for analgesia in inguinal surgery. The investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ILIH) nerve…
- Trial name
- TF-TAVI (NCT03863899)
- Testing
- Nerve block, Local infiltration, TAVI
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Gdansk
Aortic Stenosis
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis
- Trial name
- NCT00774657
- Where
- United States
- Sponsor
- Lahey Clinic
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Aortic Valve Stenosis
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
- Trial name
- REBOOT-PARADOX (NCT03863132)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Severe Aortic Stenosis, TAVI\(Transcatheter Aortic Valve Implantation\)
VARC-TAVI VALVE IMPLANTATION)
SUMMARY: The investigators are planning a clinical study to compare two methods of performing a procedure called TAVI, used in patients with severe aortic stenosis.
- Conditions
- Severe Aortic Stenosis, TAVI\(Transcatheter Aortic Valve Implantation\), Vascular Complications
- Trial name
- VARC-TAVI (NCT06177392)
- Testing
- Secondary TAVI access
- Volunteers
- 600 people
- Sponsor
- Hospital Universitario La Paz
Aortic Valve Stenosis
The Asian Pacific TAVR Multicenter Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
- Trial name
- AP TAVR (NCT02195102)
- Testing
- Transcatheter aortic valve Replacement
- Where
- 10 sites in China, Japan and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Michael Kang-Yin Lee, MD
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
Pulse Wave, Aortic Stenosis
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in…
- Trial name
- VOPRABIO (NCT03140735)
- Testing
- Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction, Control group without heart disease
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by…
- Trial name
- NCT05886517
- Testing
- Transfemoral transcatheter aortic valve implementation
- Where
- 4 sites in Italy, Spain
- Volunteers
- 200 people
- Sponsor
- AUSL Romagna Rimini
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Limited Access Aortic Valve Replacement
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS).
- Conditions
- Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
- Trial name
- LIAR (NCT04012060)
- Testing
- Limited access aortic valve replacement., Conventional aortic valve replacement
- Where
- Netherlands
- Volunteers
- 161 people
- Sponsor
- St. Antonius Hospital
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland