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ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI) | Clinical Trials | Clareo Health

COMPLETED

ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

NCT03143686•Symetis SA

Summary

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

Detailed Description

A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient has severe aortic stenosis
•Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
•Patient willing to participate in the study and provides signed EC-approved informed consent
•The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Locations (17)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RWTH Aachen

Aachen, Germany

Zentralklinik Bad Berka

Bad Berka, Germany

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, Germany

Herz-und Gefäss-Klinik GmbH

Bad Neustadt an der Saale, Germany

Schüchtermann-Schiller'sche Kliniken GmbH

Bad Rothenfelde, Germany

Uniklinik Köln Herzzentrum

Cologne, Germany

Herzzentrum Dresden Universitätsklinik

Dresden, Germany

Klinik für Tgorax und Gefässchirurgie

Essen, Germany

Universitäres Herzzentrum

Hamburg, Germany

Key Dates

Start Date

November 1, 2011

Primary Completion Date

December 1, 2012

Completion Date

November 1, 2013

Last Updated

March 19, 2018

Enrollment

250

ACTUAL participants

Conditions

Symptomatic Aortic Stenosis

Interventions

ACURATE TA™ Transapical Aortic Bioprosthesis

DEVICE

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

NCT04861805

Symptomatic Aortic Stenosis

View study

RECRUITINGNA

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

NCT05711186

Aortic Valve StenosisSymptomatic Aortic Stenosis

View study

COMPLETED

Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

Inclusion Criteria

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities

Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis

Vascular Complications and Bleeding After Transfemoral TAVI