Clinical trials: Stenosis, Aortic
Aortic Stenosis Symptomatic
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- TA-FIM (NCT03567278)
- Testing
- ACURATE TA™
- Where
- 5 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning.
- Trial name
- TAVR-Prehab (NCT03107897)
- Testing
- Pre-habilitation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- WellSpan Health
Aortic Valve Stenosis, Chronic Kidney Diseases
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute Chronic
- Trial name
- TAVIKOD (NCT07626710)
- Testing
- Trans-catheter aortic valve implantation (TAVI)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Cardiomyopathies, Hypertrophic Cardiomyopathy
The SMARTER Cardiomyopathy Study
Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses.
- Conditions
- Cardiomyopathies, Hypertrophic Cardiomyopathy, Dilated Cardiomyopathy
- Trial name
- SMARTER-CM (NCT05750147)
- Testing
- Blood Sample Collection
- Where
- 2 sites in United Kingdom
- Volunteers
- 1,000 people
- Sponsor
- Imperial College London
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Severe Aortic Stenosis
A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native…
- Trial name
- CREATE (NCT07734025)
- Testing
- Investigational Transcatheter Aortic Valve Replacement System
- Volunteers
- 30 people
- Sponsor
- Onecrea Medical Inc.
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK
A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016
- Trial name
- NCT02695147
- Testing
- TAVI
- Volunteers
- 400 people
- Sponsor
- Royal Sussex County Hospital
Aortic Stenosis
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT07205068
- Testing
- Shockwave M5 IVL Catheter, Modified Seldinger Technique
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee Graduate School of Medicine
Calcific Aortic Stenosis
Effective Management of Calcific Aortic Stenosis in the Elderly
Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.
- Trial name
- RAC (NCT03343314)
- Volunteers
- 1,101 people
- Sponsor
- French Cardiology Society
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, Aortic Valve Disease
Radial Versus Femoral Secondary Access During TAVI
The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
- Trial name
- R-TAVI (NCT03879824)
- Testing
- Secondary Radial Artery Access, Secondary Femoral Artery Access
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Carilion Clinic
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs.
- Trial name
- PROTECT (NCT02895737)
- Testing
- TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems, TAVI: CoreValve® Evolut R™, CoreValve Medtronic
- Where
- Germany
- Volunteers
- 328 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Cognitive Impairment, Older People--Abuse of
Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements
Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3.
- Conditions
- Cognitive Impairment, Older People--Abuse of, Aortic Stenosis, Severe
- Trial name
- NCT05813353
- Where
- Netherlands
- Volunteers
- 54 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Aortic Stenosis, Fibrosis
Angiogenesis and Fibrosis in Aortic Stenosis
Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible for cardiovascular disease. In this proposal, the investigators intend to build upon a highly successful programme of studies exploring…
- Conditions
- Aortic Stenosis, Fibrosis, Neovascularization, Pathologic
- Trial name
- NCT01837160
- Testing
- Cardiac MRI scan, CT-PET scan, Echocardiogram
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Valve Stenosis
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial
This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECT (NCT02448927)
- Testing
- balloon aortic valvuloplasty, Transcatheter Aortic Valve Implantation
- Where
- 4 sites in Greece, Israel
- Volunteers
- 170 people
- Sponsor
- National and Kapodistrian University of Athens
Aortic Valve Stenosis, Mitral Valve Disease
Quality of Life After Cardiac Surgery
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery.
- Conditions
- Aortic Valve Stenosis, Mitral Valve Disease, Tricuspid Valve Disease, Aorta Disease
- Trial name
- QUACS (NCT04231461)
- Testing
- Cardiac Surgery
- Where
- United Kingdom
- Volunteers
- 2,925 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
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