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

Symetis SA500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Aortic Stenosis

Interventions

ACURATE neo™ Aortic BioprosthesisDEVICE

TAVI, transcatheter aortic valve replacement. Transfemoral access.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (23)

London Health Sciences Centre, University Hospital

London, Ontario, Canada

Outcomes

Primary Outcomes

Change in total aortic regurgitation over time.

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

Time frame: 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

Incidence of all-cause mortality

Incidence of all-cause mortality at 30 days post index procedure

Time frame: 30 days post-index procedure

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

Clinical events as defined per VARC-2 consensus document

Time frame: 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

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.

Time frame: at index- Procedure

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.

Data from ClinicalTrials.gov

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