Clinical trials: Mitral Valve Repair Surgery
Nerve Block, Cardiac Surgery
Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery
This study is to evaluate whether the administration of ultrasound-guided paravertebral block (PVB) after surgery would produce better postoperative pain control and fast postoperative recovery after Robotic cardiac surgery.
- Trial name
- NCT04298580
- Testing
- PVB block
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Hypertrophic Obstructive Cardiomyopathy
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
- Trial name
- NCT02054221
- Testing
- myoectomy, Mitral valve surgery
- Where
- Russia
- Volunteers
- 82 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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 Regurgitation
Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial.
- Trial name
- NCT01703806
- Testing
- Early Surgery, Watchful Observation
- Where
- 2 sites in South Korea
- Volunteers
- 1,063 people
- Sponsor
- Asan Medical Center
Mitral Valve Regurgitation
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation…
- Trial name
- PRIMARY (NCT05051033)
- Testing
- Mitral valve repair, Transcatheter edge-to-edge repair
- Where
- 66 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
Pulmonary Hypertension
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary…
- Trial name
- NCT05699486
- Testing
- PDNO
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Attgeno AB
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Mitral Valve Prolapse
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR)…
- Trial name
- PRIMARY SDM (NCT06738537)
- Testing
- Focus Groups/Quantitative Survey for Patients, Focus Group/Quantitative Survey for HCPs, Qualitative Focus Group
- Where
- 5 sites in United States
- Volunteers
- 150 people
- Sponsor
- Northwell Health
This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device
Testing Automated Echocardiography
The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality).
- Trial name
- NCT04943965
- Testing
- Ultrasound imaging
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Tricuspid Disease, Mitral Regurgitation
Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)
The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR) in patient undergoing mitral valve surgery, is still controversial: some observational studies have suggested that performing tricuspid…
- Trial name
- NOSTRUM (NCT02996552)
- Testing
- M & T Repair Group, Mitral-Only Group
- Where
- 3 sites in Italy, Poland
- Volunteers
- 142 people
- Sponsor
- Ospedale San Raffaele
Mitral Valve Insufficiency
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation.
- Trial name
- NCT01137734
- Testing
- Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 30 people
- Sponsor
- Edwards Lifesciences
Regurgitation, Mitral
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the…
- Trial name
- IMPARED (NCT05284058)
- Testing
- Cardiac Magnetic Resonance Imaging (MRI)
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Heart Valve Diseases, Mitral Valve Insufficiency
Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR
Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in…
- Conditions
- Heart Valve Diseases, Mitral Valve Insufficiency, Heart; Dysfunction Postoperative, Cardiac Surgery, Heart; Disease, Mitral(Valve)
- Trial name
- SEP (NCT02371863)
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- UMC Utrecht
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
Mitral Regurgitation
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary…
- Trial name
- MITRA-HR (NCT03271762)
- Testing
- percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW, cardiac surgery
- Where
- 31 sites in France
- Volunteers
- 330 people
- Sponsor
- Nantes University Hospital
Mitral Valve Repair Surgery
Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography
Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity of MS before the repair and excluding residual MS…
- Trial name
- MVA (NCT01694251)
- Where
- South Korea
- Volunteers
- 86 people
- Sponsor
- Konkuk University Medical Center
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
Myocardial Protection, Minimally Invasive Surgery
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported.
- Conditions
- Myocardial Protection, Minimally Invasive Surgery, Mitral Valve Prolapse
- Trial name
- NCT04231903
- Testing
- Aortic clamp
- Volunteers
- 116 people
- Sponsor
- University of Turin, Italy
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.
Cryotherapy Effect, Post Operative Pain
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection.
- Trial name
- NCT05255146
- Testing
- Atricure Inc. Nitrous oxide Cryoprobe
- Sponsor
- University of Alberta