Clinical trials: Severe Symptomatic Aortic Stenosis, 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 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
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 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.
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.
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
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.