Clinical trials: Mitral Disease
- Condition Mitral Disease
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Disease
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.
- Trial name
- NCT05898230
- Testing
- Mitral Valve Replacement
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Corcym S.r.l
Mitral Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
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
Mitral Heart Valve Disease
Magna Mitral - 23mm
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
- Trial name
- NCT01312779
- Testing
- Implantation of CEP Magna Mitral Model 7000TFX
- Where
- 6 sites in United States, Poland
- Volunteers
- 39 people
- Sponsor
- Edwards Lifesciences
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
Mitral Regurgitation, Mitral Valve Disease
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis
- Trial name
- NCT06167213
- Testing
- SAPIEN X4 THV
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
Heart Valve Disease
On-X Heart Valve - 17mm Aortic and 23mm Mitral
This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.
- Trial name
- NCT01812174
- Testing
- 17mm aortic valve (On-X ), 23mm mitral valve (On-X)
- Where
- 10 sites in United States, Puerto Rico and 1 more
- Volunteers
- 20 people
- Sponsor
- On-X Life Technologies, Inc.
Cardiac Valve Disease
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and…
- Trial name
- MANTRA (NCT05002543)
- Where
- 52 sites in United States, Austria and 11 more
- Volunteers
- 2,150 people
- Sponsor
- Corcym S.r.l
Mitral Regurgitation (MR)
Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data…
- Trial name
- METRIX (NCT07413926)
- Testing
- Chord-X system implant
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 110 people
- Sponsor
- Artivion Inc.