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Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Primary Purpose

Aortic Valve Stenosis

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Evolut™ PRO+ System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Robles Hospital & Medical Center
  • Northwell Health
  • UPMC Pinnacle Harrisburg Campus
  • Aurora Saint Luke's Medical Center
  • The Alfred Hospital
  • IUCPQ
  • Rabin Medical Center
  • Waikato Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medtronic Evolut™ PRO+ System

Arm Description

All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.

Outcomes

Primary Outcome Measures

All-cause and cardiovascular mortality
Rate of all-cause and cardiovascular mortality
All-cause and cardiovascular mortality
Rate of all-cause and cardiovascular mortality
All stroke (disabling and non-disabling)
Rate of disabling and non-disabling stroke
All stroke (disabling and non-disabling)
Rate of disabling and non-disabling stroke
Myocardial infarction (periprocedural and spontaneous)
Rate of periprocedural and spontaneous myocardial infarction
Myocardial infarction (periprocedural and spontaneous)
Rate of periprocedural and spontaneous myocardial infarction
Acute kidney injury
Rate of acute kidney injury
Acute kidney injury
Rate of acute kidney injury
Major vascular complications
Rate of major vascular complications
Major vascular complications
Rate of major vascular complications
Life-threatening bleed
Rate of life-threatening (or disabling) bleed
Life-threatening bleed
Rate of life-threatening (or disabling) bleed
New permanent pacemaker implantation (PPI)
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
New permanent pacemaker implantation (PPI)
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
New intraventricular conduction delays
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
New intraventricular conduction delays
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
New-onset atrial fibrillation
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
New-onset atrial fibrillation
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Valve-related dysfunction requiring repeat procedure
Rare of valve-related dysfunction requiring repeat procedure
Valve-related dysfunction requiring repeat procedure
Rare of valve-related dysfunction requiring repeat procedure
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
Cardiovascular and heart failure hospitalizations
Rate of cardiovascular and heart failure hospitalizations
Cardiovascular and heart failure hospitalizations
Rate of cardiovascular and heart failure hospitalizations
Heart failure events
Rate of heart failure events
Heart failure events
Rate of heart failure events
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Change from baseline in New York Heart Association (NYHA) functional classification
Change from baseline in six-minute walk test (6MWT)
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.
Change from baseline in left ventricular ejection fraction (LVEF)
Change from baseline in global longitudinal strain (GLS)
Change from baseline in left ventricular filling pressure (E:e')
Change from baseline in stroke volume index (SVI)
Change from baseline in NT-pro B-type natriuretic peptide (NT-proBNP)

Secondary Outcome Measures

Full Information

First Posted
November 5, 2020
Last Updated
July 6, 2022
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT04639258
Brief Title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Official Title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medtronic Evolut™ PRO+ System
Arm Type
Experimental
Arm Description
All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
Intervention Type
Device
Intervention Name(s)
Medtronic Evolut™ PRO+ System
Intervention Description
TAVR treatment with Medtronic Evolut™ PRO+ System
Primary Outcome Measure Information:
Title
All-cause and cardiovascular mortality
Description
Rate of all-cause and cardiovascular mortality
Time Frame
30 days
Title
All-cause and cardiovascular mortality
Description
Rate of all-cause and cardiovascular mortality
Time Frame
6 months
Title
All stroke (disabling and non-disabling)
Description
Rate of disabling and non-disabling stroke
Time Frame
30 days
Title
All stroke (disabling and non-disabling)
Description
Rate of disabling and non-disabling stroke
Time Frame
6 months
Title
Myocardial infarction (periprocedural and spontaneous)
Description
Rate of periprocedural and spontaneous myocardial infarction
Time Frame
30 days
Title
Myocardial infarction (periprocedural and spontaneous)
Description
Rate of periprocedural and spontaneous myocardial infarction
Time Frame
6 months
Title
Acute kidney injury
Description
Rate of acute kidney injury
Time Frame
30 days
Title
Acute kidney injury
Description
Rate of acute kidney injury
Time Frame
6 months
Title
Major vascular complications
Description
Rate of major vascular complications
Time Frame
30 days
Title
Major vascular complications
Description
Rate of major vascular complications
Time Frame
6 months
Title
Life-threatening bleed
Description
Rate of life-threatening (or disabling) bleed
Time Frame
30 days
Title
Life-threatening bleed
Description
Rate of life-threatening (or disabling) bleed
Time Frame
6 months
Title
New permanent pacemaker implantation (PPI)
Description
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
Time Frame
30 days
Title
New permanent pacemaker implantation (PPI)
Description
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
Time Frame
6 months
Title
New intraventricular conduction delays
Description
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Time Frame
30 days
Title
New intraventricular conduction delays
Description
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Time Frame
6 months
Title
New-onset atrial fibrillation
Description
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Time Frame
30 days
Title
New-onset atrial fibrillation
Description
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Time Frame
6 months
Title
Valve-related dysfunction requiring repeat procedure
Description
Rare of valve-related dysfunction requiring repeat procedure
Time Frame
30 days
Title
Valve-related dysfunction requiring repeat procedure
Description
Rare of valve-related dysfunction requiring repeat procedure
Time Frame
6 months
Title
Device success (VARC-2)
Description
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
Time Frame
Through 5 years post-implant
Title
Cardiovascular and heart failure hospitalizations
Description
Rate of cardiovascular and heart failure hospitalizations
Time Frame
30 days
Title
Cardiovascular and heart failure hospitalizations
Description
Rate of cardiovascular and heart failure hospitalizations
Time Frame
6 months
Title
Heart failure events
Description
Rate of heart failure events
Time Frame
30 days
Title
Heart failure events
Description
Rate of heart failure events
Time Frame
6 months
Title
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Time Frame
Discharge (12 hours to 7 days post-procedure)
Title
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Time Frame
30 days
Title
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Time Frame
6 months
Title
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Time Frame
Discharge (12 hours to 7 days post-procedure)
Title
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Time Frame
30 days
Title
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Time Frame
6 months
Title
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Time Frame
Discharge (12 hours to 7 days post-procedure)
Title
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Time Frame
30 days
Title
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Time Frame
6 months
Title
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Time Frame
Discharge (12 hours to 7 days post-procedure)
Title
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Time Frame
30 days
Title
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Time Frame
6 months
Title
Change from baseline in New York Heart Association (NYHA) functional classification
Time Frame
30 days and 6 months
Title
Change from baseline in six-minute walk test (6MWT)
Time Frame
6 months
Title
Change from baseline in health-related Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
30 days and 6 months
Title
Change from baseline in left ventricular ejection fraction (LVEF)
Time Frame
6 months
Title
Change from baseline in global longitudinal strain (GLS)
Time Frame
6 months
Title
Change from baseline in left ventricular filling pressure (E:e')
Time Frame
6 months
Title
Change from baseline in stroke volume index (SVI)
Time Frame
6 months
Title
Change from baseline in NT-pro B-type natriuretic peptide (NT-proBNP)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
All-cause and cardiovascular mortality
Description
Rate of all-cause and cardiovascular mortality
Time Frame
Annually through 5 years
Title
All stroke (disabling and non-disabling)
Description
Rate of disabling and non-disabling strokes
Time Frame
Annually through 5 years
Title
Cardiovascular and heart failure hospitalizations
Description
Rate of cardiovascular and heart failure hospitalizations
Time Frame
Annually through 5 years
Title
Heart failure events
Description
Rate of heart failure events
Time Frame
Annually through 5 years
Title
New York Heart Association (NYHA) functional classification
Time Frame
30 days, 6 months, and annually through 5 years
Title
Change from baseline in New York Heart Association (NYHA) functional classification
Time Frame
Annually through 5 years
Title
Health-related Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
Annually through 5 years
Title
Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography
Time Frame
Annually through 5 years
Title
Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography
Time Frame
Annually through 5 years
Title
Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography
Time Frame
Annually through 5 years
Title
Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography
Time Frame
Annually through 5 years
Title
Prosthetic valve thrombosis
Description
Rate of prosthetic valve thrombosis
Time Frame
30 days, 6 months, and annually through 5 years
Title
Prosthetic valve endocarditis
Description
Rate of prosthetic valve endocarditis
Time Frame
30 days, 6 months, and annually through 5 years
Title
Bioprosthetic valve dysfunction (BVD)
Description
Rate of bioprosthetic valve dysfunction (BVD)
Time Frame
30 days, 6 months, and annually through 5 years
Title
Bioprosthetic valve failure (BVF)
Description
Rate of bioprosthetic valve failure (BVF)
Time Frame
30 days, 6 months, and annually through 5 years
Title
Valve-related dysfunction requiring repeat procedure
Description
Rate of valve-related dysfunction requiring repeat procedure
Time Frame
Annually through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Organizational Affiliation
Allina Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau, MD
Organizational Affiliation
Fondation IUCPQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3816
Country
United States
Facility Name
UPMC Pinnacle Harrisburg Campus
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
IUCPQ
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Medtronic Evolut™ EXPAND TAVR I Feasibility Study

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