Clinical trials: Aortic Valve Disease
Diseases of Mitral and Aortic Valves
Cingularbio® Heart Valve Clincial Study
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
- Trial name
- NCT02755220
- Testing
- Cingularbio® Aortic valve replacement
- Where
- 5 sites in Belgium, China and 1 more
- Volunteers
- 197 people
- Sponsor
- Shanghai Cingularbio Co. Ltd
Atrial Fibrillation, Stroke
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement.
- Conditions
- Atrial Fibrillation, Stroke, Transient Ischemic Attack, Bleeding
- Trial name
- CAREAVR (NCT02626871)
- Where
- Finland
- Volunteers
- 850 people
- Sponsor
- University of Turku
Aortic Stenosis
Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- NCT04968509
- Testing
- PCSK9 inhibitors and statins with or without ezetimibe, Statins with or without ezetimibe
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Aortic Valve Stenosis
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore…
- Trial name
- ACCESS-TAVI (NCT05503199)
- Testing
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo)., Combination of two ProGlides or ProStyles (Abbott Vascular).
- Where
- Germany
- Volunteers
- 450 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Hypertrophic Cardiomyopathy (HCM)
A Real-world HCM-cohort Trial
Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy.
- Trial name
- NCT07638033
- Testing
- Standard of care
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- Xijing Hospital
Severe Symptomatic Aortic Stenosis
Assessment of Neurologic Injury Subsequent to Transcatheter Aortic Valve Replacement: A Feasibility Study
The investigators seek to determine the feasibility of assessing neurologic injuries subsequent to transcathether aortic valve replacement (TAVR).
- Trial name
- TAVR-Neuro (NCT01927601)
- Where
- United States
- Sponsor
- University of Michigan
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Septal Hypertrophy, Obstructive Hypertrophic Cardiomyopathy
Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach
In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion.
- Trial name
- NCT05726799
- Testing
- Cryo myectomy, Myectomy
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Michele De Bonis
Heart Valve Diseases
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00630916
- Testing
- Mitroflow Aortic Heart Valve
- Where
- 26 sites in United States, Canada
- Volunteers
- 756 people
- Sponsor
- Sorin Group USA, Inc.
Coronary Artery Stenoses, Aortic Stenosis
A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced.
- Trial name
- NCT03442400
- Testing
- Volcano iFR/FFR Verrata Plus coronary pressure/flow wire
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- The Cleveland Clinic
Hypertrophic Cardiomyopathy
Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it.
- Trial name
- PREDICTVFII (NCT04157205)
- Testing
- Non-invasive ECG imaging - CardioInsight test
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Imperial College London
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
Heart Valve Diseases
Hemodynamic Performance in Stentless Heart Valves
Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.
- Trial name
- NCT00377871
- Testing
- biological heart valve prosthesis
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- University of Aarhus
Aortic Valve Disease
Prospective Long-Term Outcomes of a Standardized Ross Procedure
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular…
- Trial name
- ROSS (NCT06352671)
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Baylor Research Institute
Hypertrophic Cardiomyopathy, Genetic Disease
Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy
Investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations.
- Conditions
- Hypertrophic Cardiomyopathy, Genetic Disease, Gene Product Sequence Variation
- Trial name
- NCT03043209
- Testing
- Genomic sequencing
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- The Cleveland Clinic
Transthyretin Amyloid Cardiomyopathy, Aortic Stenosis
Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy
The goal of this prospective clinical study is to improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt).
- Trial name
- DobAttrAS (NCT06372301)
- Testing
- Dobutamine stress echocardiography
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Steen Hvitfeldt Poulsen
Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study
Background: Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Septal Hypertrophy, Mitral Valve Disease, Aortic Valve Stenosis
- Trial name
- NCT06269640
- Testing
- Septal Scoring Along Midline Endocardium
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia
Extended ECG Monitoring in HCM Patients
The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc.
- Conditions
- Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia, Ventricular Tachycardia, Atrial Fibrillation
- Trial name
- EXAMINE-HCM (NCT04056715)
- Testing
- Zio XT
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- iRhythm Technologies, Inc.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
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