Clinical trials: Aortic Stenosis Symptomatic, open to volunteers
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
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
Aortic Valve Stenosis
STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure.
- Trial name
- TVTR (NCT01737528)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- United States
- Volunteers
- 16,000 people
- Sponsor
- The Society of Thoracic Surgeons
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
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
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Cardiomyopathy, Hypertrophic Obstructive
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- LIONHEART-HCM (NCT07755904)
- Testing
- BHB-1893, Metoprolol
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Braveheart Bio, Inc.
Obstructive Hypertrophic Cardiomyopathy
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea.
- Trial name
- NCT06146660
- Testing
- Mavacamten
- Where
- 2 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy, Mavacamten
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
- Conditions
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Radiofrequency Ablation
- Trial name
- NCT06856265
- Testing
- radiofrequency ablation, Mavacamten
- Volunteers
- 40 people
- Sponsor
- Shanghai Chest Hospital
Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging.
- Trial name
- oHCM (NCT07150299)
- Testing
- Mavacamten in clinical routine use
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Aortic Stenosis, Severe
Outcome Prediction in Patients With Aortic Stenosis After TAVI
This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation
- Trial name
- PREDICT-TAVI (NCT06043180)
- Testing
- Transcatheter aortic valve implantation
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Symptomatic Aortic Stenosis
Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System
This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up…
- Trial name
- VIVA (NCT04861805)
- Testing
- Vienna Aortic Valve SE System
- Where
- 31 sites in Argentina, Brazil and 6 more
- Volunteers
- 267 people
- Sponsor
- P+F Products + Features GmbH
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
he IRON-TAVI trial is a prospective, randomized, multicenter study evaluating whether a multidomain rehabilitation program can improve outcomes in older patients undergoing transcatheter aortic valve implantation for severe…
- Conditions
- Aortic Stenosis Disease, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- IRON-TAVI (NCT07895719)
- Testing
- Personalized Multidomain Exercise Program, Oral Protein and Iron Nutritional Supplementation, Usual Care
- Where
- Italy
- Volunteers
- 450 people
- Sponsor
- University Hospital of Ferrara
Symptomatic Aortic Stenosis
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
- Trial name
- TORCH (NCT02803294)
- Testing
- transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have…
- Trial name
- NCT07807384
- Testing
- Mavacamten
- Volunteers
- 115 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Aortic Valve Stenosis
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native…
- Trial name
- LANDMARK (NCT04275726)
- Testing
- Myval THV Series, Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Where
- 54 sites in Belarus, Brazil and 15 more
- Volunteers
- 988 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Non-obstructive Hypertrophic Cardiomyopathy
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with…
- Trial name
- FORTITUDE-HCM (NCT07023614)
- Testing
- Ninerafaxstat 200mg MR
- Where
- 76 sites in United States, Austria and 9 more
- Volunteers
- 165 people
- Sponsor
- Imbria Pharmaceuticals, Inc.
Aortic Stenosis
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Trial name
- AMETHYST (NCT06924151)
- Testing
- surgical aortic valve replacement, Transcatheter aortic valve replacement
- Where
- 37 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Osaka University