Clinical trials: Valvulopathy
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
Tricuspid Regurgitation
TriClip Japan Post-Approval Study
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following…
- Trial name
- TriClip JP PAS (NCT07509658)
- Testing
- The TriClip System
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
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
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
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
Heart Valve Diseases
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market…
- Trial name
- NCT00688571
- Testing
- Melody Transcatheter Pulmonary Valve
- Where
- 7 sites in Canada, Denmark and 4 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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