Clinical trials: Valvular Aortic Stenosis, open to volunteers
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM)
AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA
The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in…
- Conditions
- Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Restrictive Cardiomyopathy
- Trial name
- Atlantis (NCT06748261)
- Testing
- CCTAI model
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
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 Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
Lumbar Spinal Stenosis, Cardiac Amyloidosis
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.
- Conditions
- Lumbar Spinal Stenosis, Cardiac Amyloidosis, ATTR Amyloidosis Wild Type, ATTR Gene Mutation
- Trial name
- NCT06034405
- Testing
- Tc99-PYP or Tc99-HDMP Scan
- Where
- 6 sites in United States
- Volunteers
- 1,663 people, healthy volunteers welcome
- Sponsor
- Columbia University
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Williams Syndrome, Duplication
Defining the Brain Phenotype of Children With Williams Syndrome
Background: Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period.
- Trial name
- NCT01132885
- Where
- United States
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- National Institute of Mental Health (NIMH)
Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy
Cardiac Amyloidosis in Patients With Aortic Stenosis
This study intends to conduct a prospective observation to investigate the prevalence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS), compare the clinical characteristics between patients with isolated AS and…
- Trial name
- NCT07170306
- Testing
- transcatheter aortic valve replacement (TAVR)
- Volunteers
- 143 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
- Trial name
- FOREST-HCM (NCT04848506)
- Testing
- Aficamten (5 - 20 mg)
- Where
- 141 sites in United States, Argentina and 17 more
- Volunteers
- 900 people
- Sponsor
- Cytokinetics
Hypertrophic Cardiomyopathy (HCM)
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
This study is a prospective interventional cohort study aimed at evaluating the therapeutic efficacy and clinical utility of Mavacamten-a targeted myosin inhibitor specifically developed for obstructive hypertrophic…
- Trial name
- BRAVE-HCM (NCT07103655)
- Testing
- mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol, diltiazem
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Cardiomyopathy, Hypertrophic
The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM.
- Trial name
- CHCS (NCT02696135)
- Where
- China
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- China National Center for Cardiovascular Diseases
Hypertrophic Cardiomyopathy (HCM)
One-stop Evaluation of Hypertrophic Cardiomyopathy in Cardiac Magnetic Resonance
This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients.
- Trial name
- NCT07336290
- Volunteers
- 10,000 people
- Sponsor
- Minjie Lu
Aortic Valve Stenosis, Heart Failure
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events…
- Trial name
- ENAVO-TAVR (NCT05672836)
- Testing
- Enavogliflozin, Standard-of-Care
- Where
- 31 sites in South Korea
- Volunteers
- 1,040 people
- Sponsor
- Duk-Woo Park, MD
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 Stenosis, Calcific
PCSK9 Inhibitors in the Treatment of Calcific Aortic 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
- PICASO (NCT07256197)
- Testing
- Treatment with PCSK9 inhibitors, Treatment without PCSK9 inhibitors
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Heart Failure, Aortic Stenosis
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize…
- Trial name
- SCRABLES (NCT02856620)
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Christine Henri