Clinical trials: Mitral Valve Surgery
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 or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
Mitral Valve Insufficiency
The Use of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
- Trial name
- NCT02180893
- Testing
- Paravertebral Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Aortic Valve Disease, Mitral Valve Disease
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.
- Trial name
- NCT05076604
- Testing
- Cardioplegia Solution, Microplegic Solution No. 1
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Washington University School of Medicine
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
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University
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
Mitral Valve Insufficiency, Coronary Artery Disease
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart.
- Trial name
- NCT00806988
- Testing
- Mitral Valve Repair, CABG
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Postoperative Atrial Fibrillation
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF).
- Trial name
- NCT02132767
- Testing
- Amiodarone, DC-cardioversion, Rate Control
- Where
- 23 sites in United States, Canada
- Volunteers
- 523 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Annular Calcification
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at…
- Trial name
- SITRAL (NCT02830204)
- Testing
- Mitral Valve Replacement (MVR) with Sapien3
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute
Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based…
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Trial name
- PREHAB (NCT02219815)
- Testing
- Prehab Intervention
- Where
- 5 sites in Canada
- Volunteers
- 89 people
- Sponsor
- St. Boniface Hospital
Atrial Fibrillation, Mitral Valve Insufficiency
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation.
- Conditions
- Atrial Fibrillation, Mitral Valve Insufficiency, Mitral Valve Stenosis
- Trial name
- NCT00903370
- Testing
- MVS, Ablation
- Where
- 21 sites in United States, Canada
- Volunteers
- 260 people
- Sponsor
- Annetine Gelijns
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.