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Clinical Trial

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

NCT: NCT02701283 · ACTIVE_NOT_RECRUITING

NCT IDNCT02701283
StatusACTIVE_NOT_RECRUITING
Start Date2016-03
Completion2029-06

Brief Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Frequently Asked Questions

What is Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients?

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients is a clinical trial registered under NCT02701283. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT02701283?

The current status of NCT02701283 (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) is: ACTIVE_NOT_RECRUITING.

When did Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients start?

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients started on 2016-03.

Related Devices

PMA P100047 Ventricular (assist) bypass Medtronic

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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