Clinical trials: Valvulopathy
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Aortic Valve Failure
Portico Valve-in-Valve Retrospective Registry
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05002088
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Severe, Symptomatic Aortic Stenosis
The SOLACE-AU Clinical Trial
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
- Trial name
- SOLACE-AU (NCT01675596)
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 11 sites in Australia
- Volunteers
- 199 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Cardiomyopathy, Hypertrophic
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
- Trial name
- ODYSSEY-HCM (NCT05582395)
- Testing
- Mavacamten
- Where
- 224 sites in United States, Australia and 21 more
- Volunteers
- 580 people
- Sponsor
- Bristol-Myers Squibb
Tricuspid Valve Insufficiency, Tricuspid Regurgitation
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement.
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases
- Trial name
- TRI-REPAIR (NCT02981953)
- Testing
- Cardioband Tricuspid
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Tricuspid Regurgitation
Edwards CLASP TR EFS
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Trial name
- CLASP TR EFS (NCT03745313)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 15 sites in United States
- Volunteers
- 65 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Mitral Valve Disease
PARTNER 3 Trial - Mitral Valve in Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03193801
- Testing
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Mitral Regurgitation
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following…
- Trial name
- NCT04729933
- Testing
- V-Wave Shunt Placement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- samir kapadia
Aortic Stenosis, Inflammation
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
The central hypothesis of this study is that TAVR leads to platelet deposition and inflammatory cell activation that can be attenuated by the potent anti-platelet and/or pleiotropic effects of ticagrelor.
- Conditions
- Aortic Stenosis, Inflammation, Thrombosis
- Trial name
- NCT02486367
- Testing
- Clopidogrel, Ticagrelor
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University Hospitals Cleveland Medical Center
Aortic Insufficiency
HAART 200 Aortic Valve Annuloplasty Trial
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when…
- Trial name
- NCT02071849
- Testing
- HAART 200 Aortic Valve Annuloplasty Device
- Where
- 4 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Biostable Science & Engineering
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Trifecta™ Long Term Follow-Up (LTFU) Study
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT01593917
- Testing
- Trifecta™ Valve
- Where
- 11 sites in United States, Canada
- Volunteers
- 329 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Regurgitation
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and…
- Trial name
- NCT02471807
- Testing
- Edwards FORMA Tricuspid Transcatheter Repair System
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Bypass Graft Redo, Heart Valve Diseases
SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of brain infarctions due to the activation of…
- Trial name
- SONORESCUE (NCT01591018)
- Testing
- sonolysis, cardiac surgery
- Where
- Czechia
- Volunteers
- 120 people
- Sponsor
- University Hospital Ostrava
Aortic Stenosis
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement.
- Trial name
- NCT03432494
- Testing
- Transcaval closure device (TCD)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tricuspid Regurgitation
Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid…
- Trial name
- HOVER (NCT02339974)
- Testing
- Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Henry Ford Health System