Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2022-06-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medtronic Evolut™ PRO+ System

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

Group Type EXPERIMENTAL

Medtronic Evolut™ PRO+ System

Intervention Type DEVICE

TAVR treatment with Medtronic Evolut™ PRO+ System

Interventions

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Medtronic Evolut™ PRO+ System

TAVR treatment with Medtronic Evolut™ PRO+ System

Intervention Type DEVICE

Eligibility Criteria

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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%

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No