Clinical trials: Aortic Stenosis Symptomatic
Aortic Stenosis Symptomatic
Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
The overall goal of this study is to develop and validate a preference assessment tool for patients who have severe aortic stenosis and are contemplating their treatment options.
- Trial name
- NCT04755426
- Testing
- AVITA--Aortic Valve Improved Treatment Approaches
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Shared Decision Making Resources
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 Stenosis Symptomatic, Aortic Valve Stenosis
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.
- Trial name
- RO-TAVI (NCT04694859)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Romania
- Volunteers
- 500 people
- Sponsor
- Romanian Society of Cardiology
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Role of Perhexiline in Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart muscle condition affecting up to 1 in 200 of the general population.
- Trial name
- RESOLVE-HCM (NCT04426578)
- Testing
- Perhexiline
- Where
- Australia
- Volunteers
- 60 people
- Sponsor
- Flinders University
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Severe and Symptomatic Aortic Stenosis
Long-term Clinical and Echographic Follow-up (More Than 4 Years) After TAVI.
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.
- Trial name
- NCT03402724
- Testing
- echographic
- Where
- France
- Volunteers
- 178 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, Valvular Heart Disease
Severe Aortic Stenosis in Patients Referred for Valve Surgery
Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to…
- Conditions
- Aortic Stenosis, Valvular Heart Disease, Symptomatic Aortic Stenosis
- Trial name
- SAS (NCT01794832)
- Where
- Norway
- Volunteers
- 500 people
- Sponsor
- Oslo University Hospital
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
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
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
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, Symptomatic Aortic Stenosis
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk.
- Trial name
- TOGETHER (NCT05711186)
- Testing
- Structured SDM, Usual Care
- Where
- 2 sites in Switzerland
- Volunteers
- 140 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Stenosis
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for…
- Trial name
- NCT02628899
- Testing
- Transfemoral TAVR, SAVR
- Where
- 11 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medstar Health Research Institute
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis
The investigators aim to identify all clinical, biological, echo and imagistic parameters that predispose to increased progression rates in a prospective observational trial which will include ONLY patients with moderate AS, with…
- Trial name
- ENIGMAS (NCT01575249)
- Where
- Romania
- Volunteers
- 200 people
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York…
- Trial name
- MEMENTO (NCT06112743)
- Testing
- Mavacamten
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb