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Clinical Trial

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

NCT: NCT01586910 · ACTIVE_NOT_RECRUITING

NCT IDNCT01586910
StatusACTIVE_NOT_RECRUITING
Start Date2012-04
Completion2026-11
SponsorMedtronic Cardiovascular (INDUSTRY)
First posted
Last updated

Brief Summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Frequently Asked Questions

What is Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).?

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). is a clinical trial registered under NCT01586910. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT01586910?

The current status of NCT01586910 (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).) is: ACTIVE_NOT_RECRUITING.

When did Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). start?

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). started on 2012-04.

Related Devices

K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage BagsMedtronic, Inc. PMA P130021Aortic valve, prosthesis, percutaneously deliveredMedtronic, Inc. PMA P870078replacement Heart-valveMedtronic, Inc. PMA P980043replacement Heart-valveMedtronic, Inc. PMA P990064replacement Heart-valveMedtronic, Inc.

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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