Trials: Critical Aortic Stenosis

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…

Medtronic Cardiovascular Results Jun 2016 89.1% serious AE View details

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

Medtronic Cardiovascular Results Dec 2018 80.0% serious AE View details

N/A N=50 Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Aortic Stenosis

Primary: Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity — 21; 8; 1; 6 participants

United States Naval Medical Center, San Diego Results Nov 2013 0.0% serious AE View details

Phase 4 N=20 Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Aortic Stenosis

Primary: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. — -25 percent change

Washington University School of Medicine Results Apr 2018 15.0% serious AE View details

N/A N=100 The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Aortic Valve Stenosis

Primary: Procedural Success — 100 Participants

Edwards Lifesciences Results Jan 2021 28.0% serious AE View details

N/A N=116 COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

Aortic Stenosis · Coronary Artery Disease

Primary: FFR 6 Months After SAVR/TAVI. — -0.0279 ratio

Universitaire Ziekenhuizen KU Leuven Results Sep 2025 0.0% serious AE View details

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…

Edwards Lifesciences Results Dec 2017 84.9% serious AE View details

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

Medtronic Cardiovascular Results Jun 2015 91.2% serious AE View details

Phase 3 N=1,873 An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

Aortic Stenosis

Primary: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) — 333; 355 Participants — p=0.591

Organon and Co Results May 2009 View details

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

Medtronic Cardiovascular Results Oct 2018 84.2% serious AE View details

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

Edwards Lifesciences Results Feb 2020 81.2% serious AE View details

N/A N=2,777 Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and 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 — 22.5; 30.8; 17.8 percentage of participants, Kaplan-Meier

Medtronic Cardiovascular Results Jul 2017 90.8% serious AE View details

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

Medtronic Cardiac Rhythm and Heart Failure Results Feb 2019 90.5% serious AE View details

N/A N=18 Medtronic CoreValve REDO Study

Aortic Valve Stenosis

Primary: Percentage of MAE Free Subjects — 10 Participants

Medtronic Cardiac Rhythm and Heart Failure Results Jan 2019 83.3% serious AE View details

Phase 2 N=149 Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Severe Aortic Stenosis · Iron-deficiency

Primary: Submaximal Exercise Test — 375; 384 meters

Oslo University Hospital Results Apr 2026 58.1% serious AE View details

N/A N=100 ADVANCE Direct Aortic Study

Aortic Stenosis · Valvular Heart Disease

Primary: All-cause Mortality — 4.4 Percentage of subjects

Medtronic Cardiac Rhythm and Heart Failure Results Jul 2018 78.3% serious AE View details

Phase 2 N=3 Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)

Aortic Valve Stenosis

Primary: Total Work Performed During a Maximal-effort Exercise Test

University of Pennsylvania Results Mar 2020 0.0% serious AE View details

Phase 2 N=23 A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Aortic Valve Stenosis

Primary: Changes in Aortic Valve Calcium Levels — 65; 215 Arbitrary Units — p=0.05

Mayo Clinic Results Jan 2020 8.3% serious AE View details

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

Medtronic Cardiovascular Results Feb 2018 65.0% serious AE View details

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

Edwards Lifesciences Results Jun 2018 66.7% serious AE View details

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

University of Michigan Results Feb 2017 0.0% serious AE View details

Phase 2 N=82 Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

Aortic Coarctation

Primary: Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening — 55 participants

Johns Hopkins University Results Mar 2016 1.2% serious AE View details

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

University of California, Los Angeles Results Apr 2019 10.0% serious AE View details

N/A N=199 The SOLACE-AU Clinical Trial

Severe, Symptomatic Aortic Stenosis

Primary: VARC-2 Composite Safety Endpoint — 12.1 percentage of patients

Edwards Lifesciences Results Apr 2019 36.7% serious AE View details

N/A N=100 EDWARDS INTUITY Valve System CADENCE-MIS Study

Aortic Valve Disease · Aortic Stenosis

Primary: Median Subject Time Spent on Cardiopulmonary Cross Clamp — 35.0; 47.5 Minutes — p=<0.0001

Edwards Lifesciences Results Jan 2019 59.8% serious AE View details

N/A N=60 Strategies for Aggressive Central Afterload Reduction in Patients With Heart Failure

Heart Failure

Primary: Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups — 1.5; -0.5; 2.0; -1.0 percentage of change in…

Mayo Clinic Results May 2014 9.8% serious AE View details

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

National Heart, Lung, and Blood Institute (NHLBI) Results Mar 2020 43.3% serious AE View details

N/A N=21 The Aortix CRS Pilot Study

Heart Failure; With Decompensation · Cardiorenal Syndrome · Cardio-Renal Syndrome

Primary: Serious Adverse Events — 18 Events

Procyrion Results Apr 2024 52.4% serious AE View details

N/A N=655 Aortoiliac Stenosis in Kidney Transplantation

Aorto-Iliac Arterial Stenosis · Peripheral Arterial Disease · Kidney Transplant Failure

Primary: Patient Survival — 322; 48; 6 Participants

Erasmus Medical Center Results Dec 2024 0.0% serious AE View details

N/A N=222 Portico TAVI Implant With Transfemoral Delivery System

Symptomatic Aortic Stenosis

Primary: All Cause Mortality — 8 Participants

Abbott Medical Devices Results Apr 2018 46.0% serious AE View details

Clinical Trial Search

N/A N=55 Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

N/A N=20 Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

N/A N=50 Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Phase 4 N=20 Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

N/A N=100 The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

N/A N=116 COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

N/A N=934 Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

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

Phase 3 N=1,873 An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

N/A N=634 CoreValve® System Australia/New Zealand Clinical Study

N/A N=295 Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

N/A N=2,777 Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

N/A N=126 Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

N/A N=18 Medtronic CoreValve REDO Study

Phase 2 N=149 Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

N/A N=100 ADVANCE Direct Aortic Study

Phase 2 N=3 Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)

Phase 2 N=23 A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

N/A N=93 The Medtronic TAVR 2.0 US Clinical Study

N/A N=120 EDWARDS INTUITY Valve System CADENCE Study

N/A N=60 Hemodynamic Comparison of Tissue Aortic Valves

Phase 2 N=82 Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

N/A N=90 Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves

N/A N=199 The SOLACE-AU Clinical Trial

N/A N=100 EDWARDS INTUITY Valve System CADENCE-MIS Study

N/A N=60 Strategies for Aggressive Central Afterload Reduction in Patients With Heart Failure

N/A N=30 Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation

N/A N=21 The Aortix CRS Pilot Study

N/A N=655 Aortoiliac Stenosis in Kidney Transplantation

N/A N=222 Portico TAVI Implant With Transfemoral Delivery System