Clinical trials: Mitral Disease
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery.
- Trial name
- NCT03714412
- Testing
- Implantation
- Where
- 2 sites in Greece, Poland
- Sponsor
- Cardiovalve Ltd.
Mitral Regurgitation
MitraClip China PMS
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for…
- Trial name
- NCT04259411
- Testing
- MitraClip procedure
- Where
- 5 sites in China
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Coronary Artery Disease
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the…
- Trial name
- NCT00157807
- Testing
- bipolar radiofrequency ablation of persistent and permanent AF
- Where
- 5 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Surgery
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Mitral Valve Insufficiency
Safety and Performance of the AccuCinch® System
This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral…
- Trial name
- NCT02624960
- Testing
- Accucinch Implant
- Sponsor
- Ancora Heart, Inc.
Mitral Regurgitation
Dragonfly-M Early Feasibility Study
To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of…
- Trial name
- NCT04528576
- Testing
- Dragonfly mitral valve repair system
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Mitral Valve Insufficiency
DragonFly EU Pivotal Study
To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk…
- Trial name
- NCT05927441
- Testing
- DragonFly Transcatheter Mitral Valve Repair System
- Where
- Germany
- Volunteers
- 168 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Valve Disease
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for…
- Trial name
- EXPLORE_MRace (NCT07796659)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Where
- 4 sites in Georgia
- Volunteers
- 100 people
- Sponsor
- Polares Medical SA
Heart Failure
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter…
- Trial name
- CASSINI-EU (NCT06414265)
- Testing
- Transcatheter mitral valve replacement
- Where
- 8 sites in Georgia, Italy and 3 more
- Volunteers
- 30 people
- Sponsor
- InnovHeart
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor
Mitral Regurgitation, Degenerative Mitral Valve Disease
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter…
- Trial name
- NCT05655897
- Testing
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
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
Mitral Valve Regurgitation
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.
- Trial name
- MERIT (NCT02948231)
- Testing
- Mistral implantation
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Mitralix
Mitral Regurgitation
Beating Heart Mitral Valve Repair With the HARPOON™ System
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
- Trial name
- RESTORE (NCT04375332)
- Testing
- HARPOON™ Beating Heart Mitral Valve Repair System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common…
- Trial name
- CoolCryo (NCT06557616)
- Where
- 2 sites in Poland
- Volunteers
- 20 people
- Sponsor
- Medinice S.A.
Mitral Stenosis, Mitral Valve Insufficiency
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant…
- Trial name
- MOMENTIS (NCT05526560)
- Testing
- MITRIS RESILIA Mitral Valve, Model 11400M
- Where
- 34 sites in United States, Canada and 2 more
- Volunteers
- 504 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Registry
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
- Trial name
- PASCALRegistry (NCT04443218)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 14 sites in Germany, Switzerland
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences