PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

NCT02987894 | Completed

• 1 other identifier: 2016-02
• Study Type: observational
• Target: 500
• Locations: 4 countries
• Sites: 23

Brief Summary

The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

Conditions

Aortic Stenosis

Keywords

TAVI; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implant; Transfemoral access; Aortic valve regurgitation

Outcome Measures

Primary Outcomes (1)

• Change in total aortic regurgitation over time.

  total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up

  post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure

Secondary Outcomes (8)

• Incidence of all-cause mortality

  30 days post-index procedure

• Clinical events as defined per VARC-2 consensus document (VARC-2)

  Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure

• Number of patients with procedural success according to VARC II criteria

  at index- Procedure

• Number of patients with device success

  7-days post-index procedure or discharge (whichever occurs first)

• Number of patients with adverse events assessed by VARC-2 Composite Safety

  30 days post-index procedure

Interventions

ACURATE neo™ Aortic Bioprosthesis DEVICE

TAVI, transcatheter aortic valve replacement. Transfemoral access.

Also known as: ACURATE TF™ Transfemoral Delivery System

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System according to the indication in the Instruction for Use. The ACURATE neo™ Aortic Bioprosthesis and its Delivery System are indicated for use in patients 75 years of age and older with severe aortic stenosis (mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or aortic valve area \< 1.0 cm2) for whom conventional surgical aortic valve replacement is considered high risk for mortality or who are not operable as determined either by a heart team consisting of a cardiologist and surgeon or by the following risk assessments: Logistic EuroSCORE \> 20% STS score \> 10%

You may qualify if:

• Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).
• Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.
• The treating physician should ensure 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 neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (23)

London Health Sciences Centre, University Hospital

London, Ontario, Canada

Location

Saint Paul's Hospital, Porvidence Health Care Institute

Vancouver, BC V6Z 1Y6, Canada

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Kerkhoff Kilnik

Bad Nauheim, 61231, Germany

Location

Immanuel Hospital Bernau- Herzzentrum Brandenburg

Bernau, 13321, Germany

Location

Universitätsklinikum

Cologne, 50924, Germany

Location

Sana-Herzzentrum Cottbus GmbH

Cottbus, 03048, Germany

Location

St Johannes Hospital

Dortmund, 44137, Germany

Location

Goethe Universität

Frankfurt, 60323, Germany

Location

Universitätklinikum Giessen

Giessen, 35392, Germany

Location

Universitätsklinikum Halle

Halle, 06097, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Städisches Klinikum Karlsruhe GmbH

Karlsruhe, 76133, Germany

Location

Helios Klinik Fur Herzzchirurgie Karlsruhe

Karlsruhe, 76185, Germany

Location

Sana Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Städische Kliniken

Neuss, 41464, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72016, Germany

Location

Ospedale Civile di Legnano

Legnano, Italy

Location

Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci

Massa, 54100, Italy

Location

University Hospital NHS

Leicester, United Kingdom

Location

Oford University Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Won-Keun Kim, Dr

  Kerckhoff-Klinik Forschungsgesellschaft mbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: December 9, 2016
• Study Start: January 2, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

CA (2); IT (2); GB (2); DE (17)