Clinical trials: Diseases of Aortic Valve
Aortic Valve Stenosis
MRI in Transcatheter Aortic Valve Replacement Patients
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV.
- Trial name
- MRI-TAVR (NCT05603026)
- Testing
- Self-expanding valve (Medtronic Evolut FX), Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University Hospitals Cleveland Medical Center
Severe Symptomatic Aortic Stenosis
Evaluation of Length of Stay After TF-TAVI
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002.
- Trial name
- FAST-TAVI (NCT02956915)
- Testing
- Transfemoral Transcatheter aortic valve implantation
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Rouen
Aortic Valve Disease
Trifecta™ Durability Study
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve.
- Trial name
- NCT01256710
- Testing
- Trifecta™ aortic bioprosthesis
- Where
- Germany
- Volunteers
- 1,151 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Femoral vs Radial Approach and MRI Evaluation of Strokes
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate.
- Trial name
- NCT00329979
- Testing
- vascular access site
- Where
- France
- Volunteers
- 152 people
- Sponsor
- University Hospital, Caen
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05332691
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
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.
Endothelial Dysfunction, Aortic Valve Disease
Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation
Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.).
- Trial name
- DYVA2 (NCT03135496)
- Testing
- Study of endothelial function biological markers
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Regurgitation Disease
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation.
- Trial name
- AWATAR (NCT07677410)
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 1,172 people
- Sponsor
- Shanghai Zhongshan Hospital
Bicuspid Aortic Valve
Identification of Genetic Causes of Bicuspid Aortic Valve Disease
BAVgenetics is a partnership between Investigators at Boston University, Brigham and Women's Hospital, and Massachusetts General Hospital dedicated to discovering the genetic causes of bicuspid aortic valve disease and associated…
- Trial name
- BAV Genetics (NCT01026571)
- Where
- United States
- Volunteers
- 11,000 people, healthy volunteers welcome
- Sponsor
- Boston University
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
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
Left Bundle-Branch Block
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker…
- Trial name
- MONITORTAVI (NCT06148883)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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 Valve Disease, Coronary Artery Disease
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide.
- Trial name
- NCT00257777
- Testing
- Myocardial protection techniques
- Where
- Norway
- Volunteers
- 350 people
- Sponsor
- Oslo 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
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