Medtronic Evolut™ EXPAND TAVR I Feasibility Study

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Medtronic Evolut™ PRO+ System

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • The Alfred Hospital
• Canada
  • Quebec, Canada, G1V 4G5
    • IUCPQ
• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
• New Zealand
  • Hamilton, New Zealand
    • Waikato Hospital
• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Los Robles Hospital & Medical Center
  • New York
    • Manhasset, New York, United States, 11030-3816
      • Northwell Health
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle Harrisburg Campus
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• Age <65 years
• Class I indication for cardiac surgery
• Bicuspid, unicuspid, or quadricuspid aortic valve
• In need of and suitable for coronary revascularization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic Evolut™ PRO+ System; All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.	Device: Medtronic Evolut™ PRO+ System; TAVR treatment with Medtronic Evolut™ PRO+ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	30 days
All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	6 months
All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling stroke	30 days
All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling stroke	6 months
Myocardial Infarction (Periprocedural and Spontaneous)	Rate of periprocedural and spontaneous myocardial infarction	30 days
Myocardial Infarction (Periprocedural and Spontaneous)	Rate of periprocedural and spontaneous myocardial infarction	6 months
Acute Kidney Injury	Rate of acute kidney injury	30 days
Acute Kidney Injury	Rate of acute kidney injury	6 months
Major Vascular Complications	Rate of major vascular complications	30 days
Major Vascular Complications	Rate of major vascular complications	6 months
Life-threatening Bleed	Rate of life-threatening (or disabling) bleed	30 days
Life-threatening Bleed	Rate of life-threatening (or disabling) bleed	6 months
New Permanent Pacemaker Implantation (PPI)	Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)	30 days
New Permanent Pacemaker Implantation (PPI)	Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)	6 months
New Intraventricular Conduction Delays	Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)	30 days
New Intraventricular Conduction Delays	Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)	6 months
New-onset Atrial Fibrillation	Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)	30 days
New-onset Atrial Fibrillation	Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)	6 months
Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	30 days
Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	6 months
Device Success (VARC-2)	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	Discharge (12 hours to 7 days post-procedure)
Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	30 days
Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	6 months
Heart Failure Events	Rate of heart failure events	30 days
Heart Failure Events	Rate of heart failure events	6 months
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	Discharge (12 hours to 7 days post-procedure)
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	30 days
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	6 months
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.	Discharge (12 hours to 7 days post-procedure)
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.	30 days
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.	6 months
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography	Discharge (12 hours to 7 days post-procedure)
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography	30 days
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography	6 months
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography	Discharge (12 hours to 7 days post-procedure)
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography	30 days
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography	6 months
Change From Baseline in New York Heart Association (NYHA) Functional Classification	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.	30 days and 6 months
Change From Baseline in Six-minute Walk Test (6MWT)	Reporting change from baseline in distance walked during 6MWT	6 months
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	30 days and 6 months
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)	Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography	6 months
Change From Baseline in Global Longitudinal Strain (GLS)	Reporting of change in GLS from baseline by echocardiography	6 months
Change From Baseline in Left Ventricular Filling Pressure (E:e')	Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography	6 months
Change From Baseline in Stroke Volume Index (SVI)	Reporting of change in stroke volume index (SVI) from baseline by echocardiography	6 months
Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)	Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	Annually through 5 years
All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling strokes	Annually through 5 years
Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	Annually through 5 years
Heart Failure Events	Rate of heart failure events	Annually through 5 years
New York Heart Association (NYHA) Functional Classification	Reporting NYHA functional classification by timepoint following attempted procedure	30 days, 6 months, and annually through 5 years
Change From Baseline in New York Heart Association (NYHA) Functional Classification	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.	Annually through 5 years
Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	Annually through 5 years
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	Annually through 5 years
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)	Annually through 5 years
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography	Annually through 5 years
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography	Annually through 5 years
Prosthetic Valve Thrombosis	Rate of prosthetic valve thrombosis	30 days, 6 months, and annually through 5 years
Prosthetic Valve Endocarditis	Rate of prosthetic valve endocarditis	30 days, 6 months, and annually through 5 years
Bioprosthetic Valve Dysfunction (BVD)	Rate of bioprosthetic valve dysfunction (BVD)	30 days, 6 months, and annually through 5 years
Bioprosthetic Valve Failure (BVF)	Rate of bioprosthetic valve failure (BVF)	30 days, 6 months, and annually through 5 years
Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	Annually through 5 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Paul Sorajja, MD, Allina Health System; Principal Investigator: Josep Rodes-Cabau, MD, Fondation IUCPQ

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: D00266108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes