Clinical trials: Regurgitation
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Degenerated Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated…
- Trial name
- NCT06467110
- Testing
- transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)
- Where
- China
- Volunteers
- 118 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Tricuspid Valve Insufficiency, Sick Sinus Syndrome
Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study
Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex.
- Trial name
- NCT02314897
- Testing
- LV pacing, RV pacing
- Where
- Singapore
- Volunteers
- 20 people
- Sponsor
- National University Hospital, Singapore
Mitral Regurgitation
Mixed Reality in MitraClip Implantation: Preliminary Case Series
The study aims to evaluate the impact of mixed reality (MR) technology, particularly using Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, on MitraClip implantation procedures.
- Trial name
- MIMIC (NCT06539416)
- Testing
- MitraClip implantation
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
Cardiovascular Diseases
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
- Trial name
- MITRACHORD (NCT02829749)
- Testing
- NeoChord beating heart mitral valve implantation, Control
- Where
- France
- Sponsor
- Hospices Civils de Lyon
Mitral Valve Stenosis With Incompetence or Regurgitation
The Effects of Levosimendan During Mitral Valve Surgery
The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery will be investigated in a prospective, double-blinded, randomized clinical trial using serum creatinine…
- Trial name
- NCT01969071
- Testing
- Levosimendan, Dobutamine
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Mitral Regurgitation
Multimodality Imaging Assessment of the Severity of Mitral Regurgitation
To investigate to assess the severity of mitral regurgitation by multimodality imaging.
- Trial name
- NCT06266858
- Testing
- rehydration, UCG, CMR
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02831270
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Konkuk University Medical Center
Mitral Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Aortic Valve Disease
A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open…
- Trial name
- CAIR-JAR (NCT07021612)
- Testing
- JenaValve, J-Valve
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Functional Mitral Regurgitation, Atrial Fibrillation
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Trial name
- AFIRE (NCT04529928)
- Testing
- Carillon Mitral Contour System
- Where
- 2 sites in Australia, Greece
- Volunteers
- 4 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Mitral Regurgitation, Functional Mitral Regurgitation
CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications.
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Trial name
- NCT06814210
- Testing
- Cerebral Embolic Protection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Xiao-dong Zhuang
Severe Mitral Valve Regurgitation (Disorder)
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER).
- Trial name
- TEERMISO (NCT05090540)
- Testing
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Centre Cardiologique du Nord
Mitral Regurgitation
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left…
- Trial name
- NCT05836480
- Testing
- mitral valve repair
- Where
- Italy
- Volunteers
- 141 people
- Sponsor
- Michele De Bonis
Mitral Regurgitation, Mitral Valve Disease
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Annular Calcification
- Trial name
- CHOICE-MI (NCT04688190)
- Where
- 43 sites in United States, Australia and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf