Clinical trial NCT04639258: Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Official title: Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All-cause and Cardiovascular Mortality
timeFrame: 30 days
measure: All-cause and Cardiovascular Mortality
timeFrame: 6 months
measure: All Stroke (Disabling and Non-disabling)
timeFrame: 30 days
measure: All Stroke (Disabling and Non-disabling)
timeFrame: 6 months
measure: Myocardial Infarction (Periprocedural and Spontaneous)
timeFrame: 30 days
measure: Myocardial Infarction (Periprocedural and Spontaneous)
timeFrame: 6 months
measure: Acute Kidney Injury
timeFrame: 30 days
measure: Acute Kidney Injury
timeFrame: 6 months
measure: Major Vascular Complications
timeFrame: 30 days
measure: Major Vascular Complications
timeFrame: 6 months
measure: Life-threatening Bleed
timeFrame: 30 days
measure: Life-threatening Bleed
timeFrame: 6 months
measure: New Permanent Pacemaker Implantation (PPI)
timeFrame: 30 days
measure: New Permanent Pacemaker Implantation (PPI)
timeFrame: 6 months
measure: New Intraventricular Conduction Delays
timeFrame: 30 days
measure: New Intraventricular Conduction Delays
timeFrame: 6 months
measure: New-onset Atrial Fibrillation
timeFrame: 30 days
measure: New-onset Atrial Fibrillation
timeFrame: 6 months
measure: Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 30 days
measure: Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 6 months
measure: Device Success (VARC-2)
timeFrame: Discharge (12 hours to 7 days post-procedure)
measure: Cardiovascular and Heart Failure Hospitalizations
timeFrame: 30 days
measure: Cardiovascular and Heart Failure Hospitalizations
timeFrame: 6 months
measure: Heart Failure Events
timeFrame: 30 days
measure: Heart Failure Events
timeFrame: 6 months
measure: Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
timeFrame: Discharge (12 hours to 7 days post-procedure)
measure: Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
timeFrame: 30 days
measure: Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
timeFrame: 6 months
measure: Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
timeFrame: Discharge (12 hours to 7 days post-procedure)
measure: Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
timeFrame: 30 days
measure: Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
timeFrame: 6 months
measure: Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
timeFrame: Discharge (12 hours to 7 days post-procedure)
measure: Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
timeFrame: 30 days
measure: Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
timeFrame: 6 months
measure: Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
timeFrame: Discharge (12 hours to 7 days post-procedure)
measure: Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
timeFrame: 30 days
measure: Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
timeFrame: 6 months
measure: Change From Baseline in New York Heart Association (NYHA) Functional Classification
timeFrame: 30 days and 6 months
measure: Change From Baseline in Six-minute Walk Test (6MWT)
timeFrame: 6 months
measure: Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days and 6 months
measure: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
timeFrame: 6 months
measure: Change From Baseline in Global Longitudinal Strain (GLS)
timeFrame: 6 months
measure: Change From Baseline in Left Ventricular Filling Pressure (E:e')
timeFrame: 6 months
measure: Change From Baseline in Stroke Volume Index (SVI)
timeFrame: 6 months
measure: Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: All-cause and Cardiovascular Mortality
timeFrame: Annually through 5 years
measure: All Stroke (Disabling and Non-disabling)
timeFrame: Annually through 5 years
measure: Cardiovascular and Heart Failure Hospitalizations
timeFrame: Annually through 5 years
measure: Heart Failure Events
timeFrame: Annually through 5 years
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 30 days, 6 months, and annually through 5 years
measure: Change From Baseline in New York Heart Association (NYHA) Functional Classification
timeFrame: Annually through 5 years
measure: Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Annually through 5 years
measure: Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
timeFrame: Annually through 5 years
measure: Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
timeFrame: Annually through 5 years
measure: Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
timeFrame: Annually through 5 years
measure: Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
timeFrame: Annually through 5 years
measure: Prosthetic Valve Thrombosis
timeFrame: 30 days, 6 months, and annually through 5 years
measure: Prosthetic Valve Endocarditis
timeFrame: 30 days, 6 months, and annually through 5 years
measure: Bioprosthetic Valve Dysfunction (BVD)
timeFrame: 30 days, 6 months, and annually through 5 years
measure: Bioprosthetic Valve Failure (BVF)
timeFrame: 30 days, 6 months, and annually through 5 years
measure: Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: Annually through 5 years
Locations:
city: Thousand Oaks
country: United States
facility: Los Robles Hospital & Medical Center
state: California
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Wormleysburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Quebec
country: Canada
facility: IUCPQ
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Allina Health System
name: Paul Sorajja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation IUCPQ
name: Josep Rodes-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
References: