Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Covidien

Status: Terminated

Conditions: Aortic Valve Stenosis

Treatments: Device: Medtronic Evolut™ PRO+ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04639258

D00266108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Medtronic Evolut™ PRO+ System

Experimental group

Description:

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

Treatment:

Device: Medtronic Evolut™ PRO+ System