N/A N=297 Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Aortic Valve Insufficiency · Aortic Valve Regurgitation · Aortic Valve Stenosis
Primary: Number of Participants With Adverse Events — 6; 14; 53; 10 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=756 Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Heart Valve Diseases
Primary: Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair — 7.1; 1.27; 0.21; 0.56 Percent occurrence per patient-year
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
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
N/A N=301 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
Mitral Valve Insufficiency · Coronary Artery Disease
Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 49.6; 46.1 ml per square meter — p=0.61
N/A N=64 Study of Aortic Root Reimplantation Procedure
Ascending Aortic Aneurism · Aortic Valve Insufficiency
Primary: Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) — 88.2; 87.7 percentage of participants
N/A N=283 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Coronary Artery Disease · Aortic Valve Disorder · Heart Failure
Primary: Subject's Percentage of Long Term Safety Performance — 1.5; 2.7; 0.2; 0.4 Percentage of events/late patient years
N/A N=140 Comparison of Two Pericardial Bioprostheses in AVR
Aortic Valve Disease
Primary: Transvalvular Mean Pressure Gradient (mPG) — 14.1; 13.9 mmHg — p=0.0004
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
N/A N=91 Mitral Implantation of TRAnscatheter vaLves
Mitral Valve Disease
Primary: Technical Success at Exit From the Cath Lab. — 23; 20; 30 Participants
N/A N=39 Magna Mitral - 23mm
Mitral Heart Valve Disease
Primary: Percent of Early Adverse Events Divided — 8.3; 0.0; 0.0; 0.0 percentage of subjects
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
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=18 Medtronic CoreValve REDO Study
Aortic Valve Stenosis
Primary: Percentage of MAE Free Subjects — 10 Participants
N/A N=88 Behavior of Valve Leaflets Following Aortic Valve Implant
Aortic-valve Replacement
Primary: Reduction in Leaflet Motion — 12 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
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=329 Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Coronary Artery Disease · Mitral Valve Regurgitation · Mitral Valve Incompetence
Primary: Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a…
N/A N=30 Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Native and Valve in Valve Aortic Valve Failure
Primary: Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory — 28 participants
N/A N=93 The Medtronic TAVR 2.0 US Clinical Study
Aortic Valve Stenosis
Primary: All-cause Mortality Rate — 1.7 percentage of participants
N/A N=11 Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
Mitral Regurgitation · Mitral Insufficiency · Mitral Annular Calcification
Primary: Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the…
N/A N=20 Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
Aortic Valve Stenosis
Primary: Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA). — 75.0; 87.5 percentage of participants analyzed — p=0.002
N/A N=934 Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
Aortic Valve Stenosis · Aortic Valve Stenosis With Insufficiency · Regurgitation, Aortic Valve
Primary: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort — 3.9; 0.9; 0.6; 0.3 Percentage of…
N/A N=30 NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Mitral Valve Failure
Primary: Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure — 30; 30; 30; 30 participants
Phase 3 N=231 Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
Aortic Valve Stenosis · Cardiovascular Diseases · Heart Valve Diseases
Primary: Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan — 11; 2 Participants — p=0.01
N/A N=197 PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
Aortic Stenosis · Cardiomyopathy, Hypertrophic
Primary: Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) — 28 Participants
N/A N=126 Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
Aortic Valve Stenosis
Primary: Composite Major Adverse Event (MAE) Free Rate — 54.2; 48.1; 51.6 Percentage of subjects
N/A N=55 Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
Aortic Valve Stenosis
Primary: Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA). — 93.6; 91.7 percentage of…
N/A N=634 CoreValve® System Australia/New Zealand Clinical Study
Aortic Valve Stenosis
Primary: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate — 0.099 probability of events at 30 days