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

Aortic Stenosis Clinical Trial

— PROGRESS  

Official title:

Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987894
• Other study ID #: 2016-02
• Status: Completed
• Start date: January 2, 2017
• Est. completion date: September 2019

Study information

• Verified date: April 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).

Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.

The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. 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.

3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:

1. 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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Device:
• ACURATE neo™ Aortic Bioprosthesis
TAVI, transcatheter aortic valve replacement. Transfemoral access.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Saint Paul's Hospital, Porvidence Health Care Institute	Vancouver
Germany	Klinikum Augsburg	Augsburg
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Kerkhoff Kilnik	Bad Nauheim
Germany	Immanuel Hospital Bernau- Herzzentrum Brandenburg	Bernau
Germany	Sana-Herzzentrum Cottbus GmbH	Cottbus
Germany	St Johannes Hospital	Dortmund
Germany	Goethe Universität	Frankfurt
Germany	Universitätklinikum Giessen	Giessen
Germany	Universitätsklinikum Halle	Halle
Germany	Universitätsklinikum Jena	Jena
Germany	Helios Klinik Fur Herzzchirurgie Karlsruhe	Karlsruhe
Germany	Städisches Klinikum Karlsruhe GmbH	Karlsruhe
Germany	Universitätsklinikum	Köln
Germany	Sana Herzzentrum Leipzig	Leipzig
Germany	Universitätsklinikum Münster	Münster
Germany	Städische Kliniken	Neuss
Germany	Universitätsklinikum Tübingen	Tübingen
Italy	Ospedale Civile di Legnano	Legnano
Italy	Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci	Massa
United Kingdom	University Hospital NHS	Leicester
United Kingdom	Oford University Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Canada,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of all-cause mortality	Incidence of all-cause mortality at 30 days post index procedure	30 days post-index procedure
Secondary	Clinical events as defined per VARC-2 consensus document (VARC-2)	Clinical events as defined per VARC-2 consensus document	Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Secondary	Number of patients with procedural success according to VARC II criteria	Procedural success is defined as; Absence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment); surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.	at index- Procedure
Secondary	Number of patients with device success	Device success is defined as: Absence of intra-procedure mortality (procedure to 24H) AND,; Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,; Intended performance of the prosthetic heart valve: No prosthesis-patient mismatch (EAOi >0.85 cm2/m2) AND,; Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND,; No moderate or severe prosthetic valve regurgitation.; In evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable.	7-days post-index procedure or discharge (whichever occurs first)
Secondary	Number of patients with adverse events assessed by VARC-2 Composite Safety	VARC-2 Composite Safety at 30 days defined as: All-cause mortality; All stroke (disabling and non-disabling); Life-threatening bleeding; Acute kidney injury - Stage 2 or 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI)	30 days post-index procedure
Secondary	Functional improvement	Functional improvement from baseline as per NYHA Functional Classification	7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Secondary	Hemodynamic function improvement from baseline	Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient	7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Secondary	Valve related dysfunction	Valve related dysfunction defined as: mean aortic valve gradient = 20mmHg, EOA =0.9-1.1 cm2, and/or DVI< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript)	7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure