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Medtronic Evolut™ EXPAND TAVR I Feasibility Study

NCT04639258 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-01-10

Study results available
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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

Interventions

DEVICE

Medtronic Evolut™ PRO+ System

TAVR treatment with Medtronic Evolut™ PRO+ System

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Paul Sorajja, MD · Allina Health System

  • Josep Rodes-Cabau, MD · Fondation IUCPQ

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2022-06-07
Completion
2022-06-07
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639258 on ClinicalTrials.gov