Clinical trials: Bicuspid Valve Disorder
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
Heart Failure, Myocardial Infarction
Teledi@Log - Tele-rehabilitation of Heart Patients
The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and technologies so that all types of heart disease patients, regardless of degree of severity, can be offered individual, customized and…
- Conditions
- Heart Failure, Myocardial Infarction, Angina Pectoris, Coronary Stenosis
- Trial name
- Teledi@log (NCT01752192)
- Testing
- Telerehabilitation programme
- Where
- 2 sites in Denmark
- Volunteers
- 151 people
- Sponsor
- Aalborg University
Aortic Valve Stenosis, Cardiovascular Diseases
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
- Trial name
- Bicuspid TAVR (NCT02394184)
- Testing
- transcatheter aortic valve replacement
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Seung-Jung Park
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
Hepatocellular Carcinoma, TACE
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced…
- Conditions
- Hepatocellular Carcinoma, TACE, Notch1, Rg3
- Trial name
- NCT02724358
- Testing
- TACE, Rg3, TACE + Rg3
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Eastern Hepatobiliary Surgery Hospital
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
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
Bicuspid
Prospective 4D CTA of BAV Competence
The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging…
- Trial name
- NCT04645862
- Testing
- CT scans
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Pennsylvania
Heart Failure
Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair
The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.
- Trial name
- MVR + CorCap (NCT00630266)
- Testing
- CorCap CSD
- Where
- 12 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Acorn Cardiovascular, Inc.
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.
Aneurysm Aortic, Aneurysm Aortic Root
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these…
- Trial name
- STORM (NCT07453251)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Sleep Apnea
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
The investigators evaluate the changes of echocardiographic and sleep apnea parameters after mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before surgery.
- Trial name
- MitralHDZ (NCT02296710)
- Testing
- Echocardiographic and sleep apnea test
- Where
- Germany
- Volunteers
- 132 people
- Sponsor
- Zisis Dimitriadis
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
Heart; Disease, Mitral(Valve)
Rapid and Easy Evaluation of Cardiac Systolic Function by Means of Mitral Valve Movements in the Emergency Department
Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to the patients, admitted to the emergency department with shortness of breath.
- Trial name
- NCT02657824
- Testing
- dyspneic patients
- Volunteers
- 113 people
- Sponsor
- Bozyaka Training and Research Hospital
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
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
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