Medtronic Evolut™ EXPAND TAVR I Feasibility Study
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: Medtronic Evolut™ PRO+ System
- Registration Number
- NCT04639258
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Detailed Description
Single-arm, descriptive, multi-center, international
All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
-
Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
-
Subject denies symptoms attributable to aortic stenosis, including but not limited to:
- Dyspnea on rest or exertion
- Angina
- Syncope in the absence of another identifiable cause
- Fatigue
- Left Ventricular Ejection Fraction (LVEF) >50%
Key
- Age <65 years
- Class I indication for cardiac surgery
- Bicuspid, unicuspid, or quadricuspid aortic valve
- In need of and suitable for coronary revascularization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medtronic Evolut™ PRO+ System Medtronic Evolut™ PRO+ System All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
- Primary Outcome Measures
Name Time Method Acute Kidney Injury 6 months Rate of acute kidney injury
New-onset Atrial Fibrillation 6 months Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Cardiovascular and Heart Failure Hospitalizations 6 months Rate of cardiovascular and heart failure hospitalizations
Major Vascular Complications 6 months Rate of major vascular complications
All-cause and Cardiovascular Mortality 6 months Rate of all-cause and cardiovascular mortality
Valve-related Dysfunction Requiring Repeat Procedure 6 months Rate of valve-related dysfunction requiring repeat procedure
All Stroke (Disabling and Non-disabling) 6 months Rate of disabling and non-disabling stroke
Myocardial Infarction (Periprocedural and Spontaneous) 6 months Rate of periprocedural and spontaneous myocardial infarction
Life-threatening Bleed 6 months Rate of life-threatening (or disabling) bleed
New Permanent Pacemaker Implantation (PPI) 6 months Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
New Intraventricular Conduction Delays 6 months Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Heart Failure Events 6 months Rate of heart failure events
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography 6 months Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography 6 months Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Change From Baseline in Global Longitudinal Strain (GLS) 6 months Reporting of change in GLS from baseline by echocardiography
Device Success (VARC-2) Discharge (12 hours to 7 days post-procedure) The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation
Change From Baseline in New York Heart Association (NYHA) Functional Classification 30 days and 6 months Reporting of NYHA classification change from baseline to 30 days and 6 months
NYHA Classification criteria:
Class I: Subjects with cardiac disease but without resulting limitations of physical activity.
Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.
Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.
Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.Change From Baseline in Six-minute Walk Test (6MWT) 6 months Reporting change from baseline in distance walked during 6MWT
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography 6 months Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography 6 months Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) 30 days and 6 months KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) 6 months Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography
Change From Baseline in Left Ventricular Filling Pressure (E:e') 6 months Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography
Change From Baseline in Stroke Volume Index (SVI) 6 months Reporting of change in stroke volume index (SVI) from baseline by echocardiography
Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP) 6 months Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Los Robles Hospital & Medical Center
🇺🇸Thousand Oaks, California, United States
Rabin Medical Center
🇮🇱Petah Tikva, Israel
IUCPQ
🇨🇦Quebec, Canada
The Alfred Hospital
🇦🇺Melbourne, Australia
Northwell Health
🇺🇸Manhasset, New York, United States
UPMC Pinnacle Harrisburg Campus
🇺🇸Wormleysburg, Pennsylvania, United States
Waikato Hospital
🇳🇿Hamilton, New Zealand
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States