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

NCT03143686 | Completed

• 1 other identifier: 2011-02
• Study Type: observational
• Target: 250
• Locations: 4 countries
• Sites: 17

Brief 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.

Conditions

Symptomatic Aortic Stenosis

Keywords

Severe symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant

  Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.

  30 days and 12 Months Follow-up

Secondary Outcomes (2)

• Procedural Success post-implantation (up to 24 hours after device implantation)

  Post-Implantation (up to 24 hours after device implantation)

• Device success at 30 days and 12 Months follow-up

  30 days and 12 Months follow-up

Study Arms (1)

ACURATE TA™ Transapical Aortic Bioprosthesis

The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted.

Device: ACURATE TA™ Transapical Aortic Bioprosthesis

Interventions

ACURATE TA™ Transapical Aortic Bioprosthesis DEVICE

ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.

Also known as: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System

ACURATE TA™ Transapical Aortic Bioprosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ACURATE TA™ is approved for use to treat patients with severe aortic stenosis. The registry includes all comer patients following the Instructions For Use.

You may qualify if:

• 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

You may not qualify if:

• Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (17)

Hospital Italiano de Buenos Aires

Buenos Aires, 4190, Argentina

Location

RWTH Aachen

Aachen, 52074, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Herz-und Gefäss-Klinik GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Schüchtermann-Schiller'sche Kliniken GmbH

Bad Rothenfelde, 49214, Germany

Location

Uniklinik Köln Herzzentrum

Cologne, 50937, Germany

Location

Herzzentrum Dresden Universitätsklinik

Dresden, 01307, Germany

Location

Klinik für Tgorax und Gefässchirurgie

Essen, 45122, Germany

Location

Universitäres Herzzentrum

Hamburg, 20251, Germany

Location

Klinik für Herzchirurgie

Karlsruhe, 76185, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Universitäts Medizin Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Sana Herzchirurgie Stuttgart GmbH

Stuttgart, 70174, Germany

Location

Policlinico s. Orsola-Malpighi

Bologna, 40138, Italy

Location

Inselspital-Stiftung

Bern, 3010, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: May 8, 2017
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: November 1, 2013
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

AR (1); CH (1); DE (14); IT (1)