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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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=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=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=295 Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Aortic Valve Stenosis With Insufficiency · Aortic Valve Stenosis
Primary: Percent of Early Adverse Events — 1.7; 1.0; 4.5; 0.0 Percentage of subjects
N/A N=18 Medtronic CoreValve REDO Study
Aortic Valve Stenosis
Primary: Percentage of MAE Free Subjects — 10 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=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=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=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=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=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
N/A N=218 PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Aortic Valve Stenosis
Primary: Number of Deaths — 16 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=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=560 The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
Severe · Symptomatic · Calcific Aortic Stenosis
Primary: Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization — 105; 102 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=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
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=54 Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Primary: Change in the Late-Life Function and Disability Instrument (LLFDI) Score — 53.2; 52.0; 52.9; 58.9 units on a scale
N/A N=16 HAART Model 300 Annuloplasty Ring
Aortic Regurgitation
Primary: Primary Safety Outcome Measure: Event-free Survival — 100 percentage of participants
N/A N=64 Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Aortic Valve Stenosis
Primary: Number of Participants With Major Vascular Complications — 2; 1 Participants
N/A N=1,453 Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Severe Aortic Stenosis
Primary: Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality — 26.0; 39.3; 14.1; 18.9 percentage of participants, Kaplan-Meier — p=<0.0001
N/A N=120 EDWARDS INTUITY Valve System CADENCE Study
Aortic Valve Disease · Aortic Stenosis
Primary: Average Subject Time Spent on Cardiopulmonary Cross Clamp — 77.5; 82.0 Minutes — p=0.3660
N/A N=37 DEFLECT I: Keystone Heart Embolic Deflection Trial
Aortic Stenosis
Primary: Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance) — 33 Participants
N/A N=349 WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Atrial Fibrillation · Aortic Valve Stenosis
Primary: Composite of All-cause Mortality, Stroke and Bleeding — 60; 64 Participants
N/A N=250 REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
Transcatheter Aortic Valve Replacement
Primary: Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure — 11.45 mmHG
N/A N=148 ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Heart Valve Diseases
Primary: Thromboembolism/Thrombosis — 0; 2.7; 2.4; 1.5 percentage of participants/patient-year
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…