Clinical trials: Aortic Stenosis
Aortic Valve Stenosis, Heart Valve Diseases
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- Trial name
- QUALITY-AVR (NCT02726087)
- Testing
- ministernotomy, Full sternotomy
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Aortic Stenosis
Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
- Trial name
- NCT03557242
- Testing
- TAVR, Warfarin plus Aspirin, Aspirin Only
- Where
- 7 sites in United States
- Volunteers
- 124 people
- Sponsor
- Medstar Health Research Institute
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Aortic Valve Stenosis, Stroke
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures.
- Trial name
- NCT01822964
- Testing
- targeted brain cooling (33°C) by RhinoChill device
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Hasselt University
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods
- Trial name
- INSERT (NCT01251328)
- Testing
- General anaesthesia, Sedation
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician…
- Trial name
- SPARC-HCM (NCT07557498)
- Testing
- Mavacamten
- Where
- United Kingdom
- Volunteers
- 362 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis, Mitral Regurgitation
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve…
- Trial name
- MITAVI (NCT04009434)
- Testing
- Mitral Valve Clipping, TAVI
- Where
- Germany
- Volunteers
- 1,162 people
- Sponsor
- Technische Universität Dresden
Anemia, Aortic Stenosis
Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement
The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve…
- Trial name
- EPICURE (NCT02390102)
- Testing
- Erythropoietin
- Where
- Canada
- Volunteers
- 117 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Stenosis, Female
Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis
The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis.
- Conditions
- Aortic Stenosis, Female, Male
- Trial name
- AWARE (NCT06677528)
- Testing
- Questionnaire
- Where
- 2 sites in Germany
- Volunteers
- 800 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Trial name
- NCT04414865
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
- Trial name
- NCT05646381
- Testing
- Pelacarsen (TQJ230) 80mg
- Where
- 140 sites in United States, Austria and 13 more
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Aortic Stenosis, Hypo-attenuated Leaflet Thickening
The HALT Biomarker Study
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis…
- Conditions
- Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration
- Trial name
- HALT (NCT04552275)
- Testing
- Proteomics Analysis
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Massachusetts General Hospital
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
Aortic Valve Stenosis
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the…
- Trial name
- POLESTAR (NCT03910751)
- Testing
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Where
- 15 sites in Belgium, Canada and 2 more
- Volunteers
- 252 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Trial name
- NCT02073851
- Testing
- TriGuard™HDH
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Keystone Heart
Aortic Valve Stenosis
First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software
The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
- Trial name
- NCT07043075
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
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