Clinical trials: AORTIC VALVE DISEASES
- Condition AORTIC VALVE DISEASES
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA…
- Trial name
- NCT03454360
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 10 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Symetis SA
Aortic Valve Insufficiency, Aortic Aneurysm
HAART Annuloplasty Device Valve Repair Registry
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice…
- Trial name
- NCT04035356
- Testing
- Aortic valve repair
- Where
- 5 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biostable Science & Engineering
Aortic Valve Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme…
- Trial name
- NCT02746809
- Testing
- CoreValve Evolut 34R TAVR system
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
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
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.
Danon Disease
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
This is a single arm Phase 2 trial to evaluate the efficacy and safety of RP-A501, a recombinant adeno-associated virus serotype 9 (rAAV9) vector containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B)…
- Trial name
- NCT06092034
- Testing
- RP-A501
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Rocket Pharmaceuticals Inc.