Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Aortic Valve Stenosis Clinical Trial

Official title:

Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04639258
• Other study ID #: D00266108
• Status: Terminated
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: January 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne
Canada	IUCPQ	Quebec
Israel	Rabin Medical Center	Petah Tikva
New Zealand	Waikato Hospital	Hamilton
United States	Northwell Health	Manhasset	New York
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Los Robles Hospital & Medical Center	Thousand Oaks	California
United States	UPMC Pinnacle Harrisburg Campus	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	Annually through 5 years
Other	All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling strokes	Annually through 5 years
Other	Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	Annually through 5 years
Other	Heart Failure Events	Rate of heart failure events	Annually through 5 years
Other	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
Other	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
Other	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
Other	Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	Annually through 5 years
Other	Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)	Annually through 5 years
Other	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
Other	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
Other	Prosthetic Valve Thrombosis	Rate of prosthetic valve thrombosis	30 days, 6 months, and annually through 5 years
Other	Prosthetic Valve Endocarditis	Rate of prosthetic valve endocarditis	30 days, 6 months, and annually through 5 years
Other	Bioprosthetic Valve Dysfunction (BVD)	Rate of bioprosthetic valve dysfunction (BVD)	30 days, 6 months, and annually through 5 years
Other	Bioprosthetic Valve Failure (BVF)	Rate of bioprosthetic valve failure (BVF)	30 days, 6 months, and annually through 5 years
Other	Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	Annually through 5 years
Primary	All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	30 days
Primary	All-cause and Cardiovascular Mortality	Rate of all-cause and cardiovascular mortality	6 months
Primary	All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling stroke	30 days
Primary	All Stroke (Disabling and Non-disabling)	Rate of disabling and non-disabling stroke	6 months
Primary	Myocardial Infarction (Periprocedural and Spontaneous)	Rate of periprocedural and spontaneous myocardial infarction	30 days
Primary	Myocardial Infarction (Periprocedural and Spontaneous)	Rate of periprocedural and spontaneous myocardial infarction	6 months
Primary	Acute Kidney Injury	Rate of acute kidney injury	30 days
Primary	Acute Kidney Injury	Rate of acute kidney injury	6 months
Primary	Major Vascular Complications	Rate of major vascular complications	30 days
Primary	Major Vascular Complications	Rate of major vascular complications	6 months
Primary	Life-threatening Bleed	Rate of life-threatening (or disabling) bleed	30 days
Primary	Life-threatening Bleed	Rate of life-threatening (or disabling) bleed	6 months
Primary	New Permanent Pacemaker Implantation (PPI)	Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)	30 days
Primary	New Permanent Pacemaker Implantation (PPI)	Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)	6 months
Primary	New Intraventricular Conduction Delays	Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)	30 days
Primary	New Intraventricular Conduction Delays	Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)	6 months
Primary	New-onset Atrial Fibrillation	Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)	30 days
Primary	New-onset Atrial Fibrillation	Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)	6 months
Primary	Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	30 days
Primary	Valve-related Dysfunction Requiring Repeat Procedure	Rate of valve-related dysfunction requiring repeat procedure	6 months
Primary	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)
Primary	Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	30 days
Primary	Cardiovascular and Heart Failure Hospitalizations	Rate of cardiovascular and heart failure hospitalizations	6 months
Primary	Heart Failure Events	Rate of heart failure events	30 days
Primary	Heart Failure Events	Rate of heart failure events	6 months
Primary	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)
Primary	Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	30 days
Primary	Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	6 months
Primary	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)
Primary	Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.	30 days
Primary	Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.	6 months
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	Change From Baseline in Six-minute Walk Test (6MWT)	Reporting change from baseline in distance walked during 6MWT	6 months
Primary	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
Primary	Change From Baseline in Left Ventricular Ejection Fraction (LVEF)	Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography	6 months
Primary	Change From Baseline in Global Longitudinal Strain (GLS)	Reporting of change in GLS from baseline by echocardiography	6 months
Primary	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
Primary	Change From Baseline in Stroke Volume Index (SVI)	Reporting of change in stroke volume index (SVI) from baseline by echocardiography	6 months
Primary	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