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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04639258




Registration number
NCT04639258
Ethics application status
Date submitted
5/11/2020
Date registered
20/11/2020
Date last updated
10/01/2024

Titles & IDs
Public title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Scientific title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Secondary ID [1] 0 0
D00266108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Evolut™ PRO+ System

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


Treatment: Devices: Medtronic Evolut™ PRO+ System
TAVR treatment with Medtronic Evolut™ PRO+ System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause and Cardiovascular Mortality
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
All-cause and Cardiovascular Mortality
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
All Stroke (Disabling and Non-disabling)
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
All Stroke (Disabling and Non-disabling)
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Myocardial Infarction (Periprocedural and Spontaneous)
Timepoint [5] 0 0
30 days
Primary outcome [6] 0 0
Myocardial Infarction (Periprocedural and Spontaneous)
Timepoint [6] 0 0
6 months
Primary outcome [7] 0 0
Acute Kidney Injury
Timepoint [7] 0 0
30 days
Primary outcome [8] 0 0
Acute Kidney Injury
Timepoint [8] 0 0
6 months
Primary outcome [9] 0 0
Major Vascular Complications
Timepoint [9] 0 0
30 days
Primary outcome [10] 0 0
Major Vascular Complications
Timepoint [10] 0 0
6 months
Primary outcome [11] 0 0
Life-threatening Bleed
Timepoint [11] 0 0
30 days
Primary outcome [12] 0 0
Life-threatening Bleed
Timepoint [12] 0 0
6 months
Primary outcome [13] 0 0
New Permanent Pacemaker Implantation (PPI)
Timepoint [13] 0 0
30 days
Primary outcome [14] 0 0
New Permanent Pacemaker Implantation (PPI)
Timepoint [14] 0 0
6 months
Primary outcome [15] 0 0
New Intraventricular Conduction Delays
Timepoint [15] 0 0
30 days
Primary outcome [16] 0 0
New Intraventricular Conduction Delays
Timepoint [16] 0 0
6 months
Primary outcome [17] 0 0
New-onset Atrial Fibrillation
Timepoint [17] 0 0
30 days
Primary outcome [18] 0 0
New-onset Atrial Fibrillation
Timepoint [18] 0 0
6 months
Primary outcome [19] 0 0
Valve-related Dysfunction Requiring Repeat Procedure
Timepoint [19] 0 0
30 days
Primary outcome [20] 0 0
Valve-related Dysfunction Requiring Repeat Procedure
Timepoint [20] 0 0
6 months
Primary outcome [21] 0 0
Device Success (VARC-2)
Timepoint [21] 0 0
Discharge (12 hours to 7 days post-procedure)
Primary outcome [22] 0 0
Cardiovascular and Heart Failure Hospitalizations
Timepoint [22] 0 0
30 days
Primary outcome [23] 0 0
Cardiovascular and Heart Failure Hospitalizations
Timepoint [23] 0 0
6 months
Primary outcome [24] 0 0
Heart Failure Events
Timepoint [24] 0 0
30 days
Primary outcome [25] 0 0
Heart Failure Events
Timepoint [25] 0 0
6 months
Primary outcome [26] 0 0
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Timepoint [26] 0 0
Discharge (12 hours to 7 days post-procedure)
Primary outcome [27] 0 0
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Timepoint [27] 0 0
30 days
Primary outcome [28] 0 0
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Timepoint [28] 0 0
6 months
Primary outcome [29] 0 0
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Timepoint [29] 0 0
Discharge (12 hours to 7 days post-procedure)
Primary outcome [30] 0 0
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Timepoint [30] 0 0
30 days
Primary outcome [31] 0 0
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Timepoint [31] 0 0
6 months
Primary outcome [32] 0 0
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Timepoint [32] 0 0
Discharge (12 hours to 7 days post-procedure)
Primary outcome [33] 0 0
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Timepoint [33] 0 0
30 days
Primary outcome [34] 0 0
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Timepoint [34] 0 0
6 months
Primary outcome [35] 0 0
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Timepoint [35] 0 0
Discharge (12 hours to 7 days post-procedure)
Primary outcome [36] 0 0
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Timepoint [36] 0 0
30 days
Primary outcome [37] 0 0
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Timepoint [37] 0 0
6 months
Primary outcome [38] 0 0
Change From Baseline in New York Heart Association (NYHA) Functional Classification
Timepoint [38] 0 0
30 days and 6 months
Primary outcome [39] 0 0
Change From Baseline in Six-minute Walk Test (6MWT)
Timepoint [39] 0 0
6 months
Primary outcome [40] 0 0
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [40] 0 0
30 days and 6 months
Primary outcome [41] 0 0
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Timepoint [41] 0 0
6 months
Primary outcome [42] 0 0
Change From Baseline in Global Longitudinal Strain (GLS)
Timepoint [42] 0 0
6 months
Primary outcome [43] 0 0
Change From Baseline in Left Ventricular Filling Pressure (E:e')
Timepoint [43] 0 0
6 months
Primary outcome [44] 0 0
Change From Baseline in Stroke Volume Index (SVI)
Timepoint [44] 0 0
6 months
Primary outcome [45] 0 0
Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)
Timepoint [45] 0 0
6 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2022
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Israel
State/province [6] 0 0
Petah Tikva
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04639258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sorajja, MD
Address 0 0
Allina Health System
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04639258