Clinical trials: Aortic Stenosis Symptomatic, active
Obstructive Hypertrophic Cardiomyopathy
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).
- Trial name
- CAMELLIA-HCM (NCT07023341)
- Testing
- BAY3723113
- Where
- 23 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Bayer
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
Aortic Valve Stenosis
Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
Over the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic…
- Trial name
- BEST (NCT05454150)
- Testing
- balloon-expandable valve, self-expanding valve
- Where
- 21 sites in France
- Volunteers
- 1,960 people
- Sponsor
- University Hospital, Lille
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.
Aortic Valve Stenosis
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or…
- Trial name
- DEDICATE (NCT03112980)
- Testing
- Transcatheter aortic valve implantation, Surgical aortic valve replacement
- Where
- 43 sites in Germany
- Volunteers
- 1,414 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
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 Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
- Trial name
- SONATA-HCM (NCT06481891)
- Testing
- Sotagliflozin
- Where
- 108 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Lexicon Pharmaceuticals
Severe Aortic Valve Stenosis
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
- Trial name
- BSC07 (NCT05847751)
- Testing
- Aortic valve replacement
- Where
- 7 sites in Egypt, Lebanon and 1 more
- Volunteers
- 51 people
- Sponsor
- Ceric Sàrl
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
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
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
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
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT06253221
- Testing
- Mavacamten
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 44 people
- Sponsor
- Bristol-Myers Squibb