Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Overview

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of moderate, symptomatic aortic stenosis and severe, asymptomatic aortic stenosis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

Detailed Description

Single-arm, two-cohort, 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.

Interventions

  • Device: Medtronic Evolut™ PRO+ System
    • TAVR treatment with Medtronic Evolut™ PRO+ System

Arms, Groups and Cohorts

  • Experimental: Medtronic Evolut™ PRO+ System
    • All study subjects in Cohort A (Moderate, Symptomatic Aortic Stenosis) and Cohort B (Severe, Asymptomatic Aortic Stenosis) will be treated with the Medtronic Evolut™ PRO+ TAVR System.

Clinical Trial Outcome Measures

Primary Measures

  • All-cause and cardiovascular mortality
    • Time Frame: 30 days
    • Rate of all-cause and cardiovascular mortality
  • All-cause and cardiovascular mortality
    • Time Frame: 6 months
    • Rate of all-cause and cardiovascular mortality
  • All stroke (disabling and non-disabling)
    • Time Frame: 30 days
    • Rate of disabling and non-disabling stroke
  • All stroke (disabling and non-disabling)
    • Time Frame: 6 months
    • Rate of disabling and non-disabling stroke
  • Myocardial infarction (periprocedural and spontaneous)
    • Time Frame: 30 days
    • Rate of periprocedural and spontaneous myocardial infarction
  • Myocardial infarction (periprocedural and spontaneous)
    • Time Frame: 6 months
    • Rate of periprocedural and spontaneous myocardial infarction
  • Acute kidney injury
    • Time Frame: 30 days
    • Rate of acute kidney injury
  • Acute kidney injury
    • Time Frame: 6 months
    • Rate of acute kidney injury
  • Major vascular complications
    • Time Frame: 30 days
    • Rate of major vascular complications
  • Major vascular complications
    • Time Frame: 6 months
    • Rate of major vascular complications
  • Life-threatening bleed
    • Time Frame: 30 days
    • Rate of life-threatening (or disabling) bleed
  • Life-threatening bleed
    • Time Frame: 6 months
    • Rate of life-threatening (or disabling) bleed
  • New permanent pacemaker implantation (PPI)
    • Time Frame: 30 days
    • Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
  • New permanent pacemaker implantation (PPI)
    • Time Frame: 6 months
    • Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
  • New intraventricular conduction delays
    • Time Frame: 30 days
    • Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
  • New intraventricular conduction delays
    • Time Frame: 6 months
    • Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
  • New-onset atrial fibrillation
    • Time Frame: 30 days
    • Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
  • New-onset atrial fibrillation
    • Time Frame: 6 months
    • Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
  • Valve-related dysfunction requiring repeat procedure
    • Time Frame: 30 days
    • Rare of valve-related dysfunction requiring repeat procedure
  • Valve-related dysfunction requiring repeat procedure
    • Time Frame: 6 months
    • Rare of valve-related dysfunction requiring repeat procedure
  • Device success (VARC-2)
    • Time Frame: Through 5 years post-implant
    • 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
  • Cardiovascular and heart failure hospitalizations
    • Time Frame: 30 days
    • Rate of cardiovascular and heart failure hospitalizations
  • Cardiovascular and heart failure hospitalizations
    • Time Frame: 6 months
    • Rate of cardiovascular and heart failure hospitalizations
  • Heart failure events
    • Time Frame: 30 days
    • Rate of heart failure events
  • Heart failure events
    • Time Frame: 6 months
    • Rate of heart failure events
  • Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
    • Time Frame: Discharge (12 hours to 7 days post-procedure)
  • Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
    • Time Frame: 30 days
  • Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
    • Time Frame: 6 months
  • Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
    • Time Frame: Discharge (12 hours to 7 days post-procedure)
  • Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
    • Time Frame: 30 days
  • Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
    • Time Frame: 6 months
  • Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
    • Time Frame: Discharge (12 hours to 7 days post-procedure)
  • Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
    • Time Frame: 30 days
  • Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
    • Time Frame: 6 months
  • Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
    • Time Frame: Discharge (12 hours to 7 days post-procedure)
  • Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
    • Time Frame: 30 days
  • Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
    • Time Frame: 6 months
  • Change from baseline in New York Heart Association (NYHA) functional classification
    • Time Frame: 30 days and 6 months
  • Change from baseline in six-minute walk test (6MWT)
    • Time Frame: 6 months
  • Change from baseline in health-related Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Time Frame: 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)
    • Time Frame: 6 months
  • Change from baseline in global longitudinal strain (GLS)
    • Time Frame: 6 months
  • Change from baseline in left ventricular filling pressure (E:e’)
    • Time Frame: 6 months
  • Change from baseline in stroke volume index (SVI)
    • Time Frame: 6 months
  • Change from baseline in NT-pro B-type natriuretic peptide (NT-proBNP)
    • Time Frame: 6 months

Participating in This Clinical Trial

Key Inclusion Criteria:

Cohort A (Moderate, Symptomatic Aortic Stenosis)

  • Moderate aortic stenosis (aortic valve area >1.0 cm^2 & <1.5 cm^2) – New York Heart Association (NYHA) functional classification ≥II, with symptoms attributable to aortic stenosis – Left Ventricular Ejection Fraction (LVEF) >20% by 2-D echo Key Exclusion Criteria:
  • Cohort A (Moderate, Symptomatic Aortic Stenosis)

  • Age <65 years – Class I indication for cardiac surgery – Bicuspid, unicuspid, or quadricuspid aortic valve – In need of and suitable for coronary revascularization Key Inclusion Criteria:
  • Cohort B (Severe, Asymptomatic Aortic Stenosis)

  • 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:
  • Cohort B (Severe, Asymptomatic Aortic Stenosis)

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

    Minimum Age: 65 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Medtronic Cardiovascular
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Paul Sorajja, MD, Principal Investigator, Allina Health System
      • Josep Rodes-Cabau, MD, Principal Investigator, IUCPQ
    • Overall Contact(s)
      • Evolut EXPAND TAVR I Feasibility Study Team, 7635266237, rs.newtavrindications@medtronic.com

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