N/A N=50 The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study
Mitral Regurgitation · Pulmonary Hypertension
Primary: Impaired Post-operative Functional Capacity — 35 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=40 TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
Tricuspid Valve Insufficiency · Tricuspid Regurgitation · Tricuspid Valve Regurgitation
Primary: Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) — 3; 1 Participants
N/A N=98 TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
Tricuspid Valve Insufficiency
Primary: Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade — 71 Participants
N/A N=401 Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Mild Tricuspid Regurgitation · Moderate Tricuspid Regurgitation · Tricuspid Regurgitation
Primary: Percentage of Participants With Treatment Failure — 10.2; 3.9 percentage of participants
N/A N=25 The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Tricuspid Valve Regurgitation
Primary: All-cause Mortality — 2 Participants
N/A N=81 COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Pulmonary Valve Insufficiency · Pulmonary Regurgitation · Dysfunctional RVOT Conduit
Primary: Freedom From Device or Procedure Related Death or Reintervention — 97.1 percentage of participants
N/A N=65 Edwards CLASP TR EFS
Tricuspid Regurgitation
Primary: Composite Major Adverse Event (MAE) Rate — 6 Participants
N/A N=90 Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
Eisenmenger Syndrome
Primary: Number of Participants Who Developed Infective Endocarditis — 9 participants
Phase 3 N=15 Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
Tricuspid Regurgitation
Primary: Procedural Success — 42.86 Percentage of Participants
N/A N=85 EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Tricuspid Valve Insufficiency
Primary: Mean Gradient Across the Tricuspid Valve — 1.3; 2.0; 1.9 mmHg
N/A N=1,022 Aortic Valve Replacement With Trifecta(TM)
Aortic Valve Insufficiency · Regurgitation, Aortic Valve · Aortic Valve Incompetence
Primary: Late Adverse Event Rates — 1.90; 0; 2.61; 0.12 percentage of events/late patient years
Phase 3 N=128 Ertugliflozin for Functional Mitral Regurgitation
Mitral Valve Insufficiency · Left Ventricular Systolic Dysfunction
Primary: Change of EROA — 0.03; -0.05 square cm — p=<0.001
N/A N=22 Endothelial Function and Cardiac Output in RV Pacing
Bradycardia
Primary: Endothelial Function Assessed by Flow Mediated Vasodilatation — 1.96; 1.73 EndoPAT index (EnFI)
Phase 2 N=55 Feasibility Study of a Percutaneous Mitral Valve Repair System.
Mitral Valve Insufficiency · Mitral Valve Regurgitation · Mitral Valve Incompetence
Primary: Mitral Regurgitation Severity — 0.0; 0.0; 5.6; 38.9 Percentage of participants
N/A N=67 TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Right Ventricular Dysfunction
Primary: 3D RVEF (Baseline) — 44.71; 48.74; 49.11 percentage — p=0.0167
N/A N=64 Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Tricuspid Valve Regurgitation · Tricuspid Valve Insufficiency
Primary: Change in the Degree of Tricuspid Regurgitation — 27; 18; 6; 6 participants
N/A N=84 Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
Heart Valve Diseases
Primary: Intensity (Highness) of the Sound From Mechanical Heart Valves — 43; 41; 40 dB (decibel) — p=<0.05
N/A N=208 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?
Barlow's Disease · Prolapse; Mitral
Primary: Cardiac Death — 3.9; 3.8 percentage of participants with event
Phase 2 N=25 Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
Tetralogy of Fallot · Pulmonary Insufficiency
Primary: Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. — 187.1; 175.4; 205.0; 86.0 ml
N/A N=111 Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
Mitral Valve Insufficiency · Atrial Fibrillation · Heart Failure
Primary: Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization — 25.5 mmHg
N/A N=120 Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
Mitral Valve Insufficiency · Heart Failure
Primary: Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months — -7.07; 3.32 ml/beat
N/A N=200 PRESERVE-MITRAL Post-Market Registry
Mitral Valve Disease
Primary: Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure — 97.8 percentage of participants
N/A N=61 Cardioband With Transfemoral Delivery System
Mitral Regurgitation
Primary: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects — 2; 1; 2; 4 Participants
N/A N=220 Edwards PASCAL Transcatheter Valve Repair System Registry
Mitral Valve Insufficiency
Primary: Major Adverse Events (MAEs) — 9; 2; 0; 1 Participants
N/A N=610 REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart Failure
Primary: Percentage of Patients Worsened for Clinical Composite Response — 21.5; 16 Percentage of participants worsened — p=0.10
Phase 2 N=251 Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Mitral Valve Insufficiency · Coronary Artery Disease
Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 54.6; 60.7 ml per square meter of body-surface area — p=0.18
N/A N=154 RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Embolic Stroke of Undetermined Source · Transient Ischemic Attack · Right-To-Left Atrial Shunt
Primary: Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) — 74; 47; 24; 97 Participants — p=<0.001
N/A N=34 Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Tricuspid Valve Regurgitation
Primary: Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE — 10 Participants
N/A N=60 Hemodynamic Comparison of Tissue Aortic Valves
Aortic Valve Stenosis
Primary: Aortic Valve Mean Gradient (mm Hg) at Peak Exercise — 11; 14; 11 mm Hg
N/A N=19 NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Functional Mitral Regurgitation
Primary: The Primary Endpoint is Technical Success — 17 Participants