Medtronic Evolut™ EXPAND TAVR I Feasibility Study

NCT04639258 | Terminated Results DMC FDA Device

• 1 other identifier: D00266108
• Study Type: interventional
• Target: 11
• Locations: 5 countries
• Sites: 8

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (45)

• All-cause and Cardiovascular Mortality

  Rate of all-cause and cardiovascular mortality

  30 days

• All-cause and Cardiovascular Mortality

  Rate of all-cause and cardiovascular mortality

  6 months

• All Stroke (Disabling and Non-disabling)

  Rate of disabling and non-disabling stroke

  30 days

• All Stroke (Disabling and Non-disabling)

  Rate of disabling and non-disabling stroke

  6 months

• Myocardial Infarction (Periprocedural and Spontaneous)

  Rate of periprocedural and spontaneous myocardial infarction

  30 days

• Myocardial Infarction (Periprocedural and Spontaneous)

  Rate of periprocedural and spontaneous myocardial infarction

  6 months

• Acute Kidney Injury

  Rate of acute kidney injury

  30 days

• Acute Kidney Injury

  Rate of acute kidney injury

  6 months

• Major Vascular Complications

  Rate of major vascular complications

  30 days

• Major Vascular Complications

  Rate of major vascular complications

  6 months

• Life-threatening Bleed

  Rate of life-threatening (or disabling) bleed

  30 days

• Life-threatening Bleed

  Rate of life-threatening (or disabling) bleed

  6 months

• New Permanent Pacemaker Implantation (PPI)

  Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

  30 days

• New Permanent Pacemaker Implantation (PPI)

  Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

  6 months

• New Intraventricular Conduction Delays

  Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

  30 days

• New Intraventricular Conduction Delays

  Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

  6 months

• New-onset Atrial Fibrillation

  Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

  30 days

• New-onset Atrial Fibrillation

  Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

  6 months

• Valve-related Dysfunction Requiring Repeat Procedure

  Rate of valve-related dysfunction requiring repeat procedure

  30 days

• Valve-related Dysfunction Requiring Repeat Procedure

  Rate of valve-related dysfunction requiring repeat procedure

  6 months

• 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)

• Cardiovascular and Heart Failure Hospitalizations

  Rate of cardiovascular and heart failure hospitalizations

  30 days

• Cardiovascular and Heart Failure Hospitalizations

  Rate of cardiovascular and heart failure hospitalizations

  6 months

• Heart Failure Events

  Rate of heart failure events

  30 days

• Heart Failure Events

  Rate of heart failure events

  6 months

• 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)

• Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography

  Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  30 days

• Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography

  Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  6 months

• 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)

• Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography

  Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  30 days

• Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography

  Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  6 months

• 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)

• 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

• 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

• 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)

• 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

• 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

• 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

• Change From Baseline in Six-minute Walk Test (6MWT)

  Reporting change from baseline in distance walked during 6MWT

  6 months

• 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

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

  Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography

  6 months

• Change From Baseline in Global Longitudinal Strain (GLS)

  Reporting of change in GLS from baseline by echocardiography

  6 months

• 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

• Change From Baseline in Stroke Volume Index (SVI)

  Reporting of change in stroke volume index (SVI) from baseline by echocardiography

  6 months

• 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

Other Outcomes (16)

• All-cause and Cardiovascular Mortality

  Annually through 5 years

• All Stroke (Disabling and Non-disabling)

  Annually through 5 years

• Cardiovascular and Heart Failure Hospitalizations

  Annually through 5 years

Study Arms (1)

Medtronic Evolut™ PRO+ System

EXPERIMENTAL

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

Device: Medtronic Evolut™ PRO+ System

Interventions

Medtronic Evolut™ PRO+ System DEVICE

TAVR treatment with Medtronic Evolut™ PRO+ System

Medtronic Evolut™ PRO+ System

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (8)

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Northwell Health

Manhasset, New York, 11030-3816, United States

Location

UPMC Pinnacle Harrisburg Campus

Wormleysburg, Pennsylvania, 17043, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

The Alfred Hospital

Melbourne, Australia

Location

IUCPQ

Québec, G1V 4G5, Canada

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Limitations and Caveats

Early termination of the study prior to any attempted TAVR procedures led to no evaluable subjects for data analysis.

Results Point of Contact

• Title: Robert Waltonen
• Organization: Medtronic Structural Heart & Aortic

robert.waltonen@medtronic.com

763-526-0424

Study Officials

• Paul Sorajja, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

• Josep Rodes-Cabau, MD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 20, 2020
• Study Start: May 28, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2024-01

Locations

AU (1); US (4); CA (1); IL (1); NZ (1)