Clinical trials: Mitral Disease
Mitral Valve Regurgitation
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
- Trial name
- DYANA (NCT00833014)
- Testing
- Dynamic Annuloplasty Ring (with option to adjust off-pump)
- Where
- 5 sites in Canada, Germany and 1 more
- Volunteers
- 130 people
- Sponsor
- MiCardia Corporation
Persistent Atrial Fibrillation
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
- Trial name
- ReMATCH (NCT06735534)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 376 people
- Sponsor
- Boston Scientific Corporation
Mitral Valve Regurgitation (Degenerative or Functional)
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty…
- Trial name
- MARCH (NCT07188233)
- Testing
- Transcatheter Mitral Valve Repair
- Where
- 2 sites in Georgia, Lithuania
- Volunteers
- 5 people
- Sponsor
- HVR Cardio Oy
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - First In Human Israel
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-FIHIL (NCT05688514)
- Testing
- Innovalve MR system
- Where
- Israel
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Diseases of Mitral and Aortic Valves
Cingularbio® Heart Valve Clincial Study
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
- Trial name
- NCT02755220
- Testing
- Cingularbio® Aortic valve replacement
- Where
- 5 sites in Belgium, China and 1 more
- Volunteers
- 197 people
- Sponsor
- Shanghai Cingularbio Co. Ltd
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the…
- Trial name
- NCT05417945
- Testing
- JensClip transcatheter valve repair system
- Volunteers
- 124 people
- Sponsor
- Jenscare Scientific
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Arrhythmias, Cardiac, Atrial Fibrillation
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode…
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases
- Trial name
- NCT06358391
- Testing
- TS-RF Transseptal Needle, BRK Transseptal Needle
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Starmed
Mitral Valve Repair, Mitral Regurgitation
ChordArt System for Mitral Regurgitation
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach.
- Conditions
- Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency
- Trial name
- CHAGALL (NCT03581656)
- Testing
- ChordArt System
- Where
- Lithuania
- Volunteers
- 5 people
- Sponsor
- CoreMedic GmbH
Mitral Regurgitation, Mitral Disease
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Trial name
- SAPIEN M3 EFS (NCT03230747)
- Testing
- Edwards SAPIEN M3 System
- Where
- 9 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Anchord Mitral Chordal Repair System - FIH
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal…
- Trial name
- NCT07671820
- Testing
- Anchord device implantation
- Volunteers
- 5 people
- Sponsor
- Lifecord Otd
Cardiovascular Diseases
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation.
- Trial name
- RESHAPE-HF (NCT01772108)
- Testing
- MitraClip
- Where
- 29 sites in Austria, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Regurgitation
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- Trial name
- CINCH-2 (NCT00800046)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Ancora Heart, 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
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral…
- Trial name
- HRT (NCT03511716)
- Testing
- HRT Mitral Bridge Mitral Valve Repair
- Where
- Czechia
- Volunteers
- 34 people
- Sponsor
- Heart Repair Technologies, Inc.
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.
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited