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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE neo™ Aortic Bioprosthesis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada, BC V6Z 1Y6
    • Saint Paul's Hospital, Porvidence Health Care Institute
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre, University Hospital
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka
  • Bad Nauheim, Germany, 61231
    • Kerkhoff Kilnik
  • Bernau, Germany, 13321
    • Immanuel Hospital Bernau- Herzzentrum Brandenburg
  • Cottbus, Germany, 03048
    • Sana-Herzzentrum Cottbus GmbH
  • Dortmund, Germany, 44137
    • St Johannes Hospital
  • Frankfurt, Germany, 60323
    • Goethe Universität
  • Giessen, Germany, 35392
    • Universitätklinikum Giessen
  • Halle, Germany, 06097
    • Universitätsklinikum Halle
  • Jena, Germany, 07743
    • Universitätsklinikum Jena
  • Karlsruhe, Germany, 76133
    • Städisches Klinikum Karlsruhe GmbH
  • Karlsruhe, Germany, 76185
    • Helios Klinik Fur Herzzchirurgie Karlsruhe
  • Köln, Germany, 50924
    • Universitätsklinikum
  • Leipzig, Germany, 04289
    • Sana Herzzentrum Leipzig
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Neuss, Germany, 41464
    • Städische Kliniken
  • Tübingen, Germany, 72016
    • Universitätsklinikum Tübingen
• Italy
  • Legnano, Italy
    • Ospedale Civile di Legnano
  • Massa, Italy, 54100
    • Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci
• United Kingdom
  • Leicester, United Kingdom
    • University Hospital NHS
  • Oxford, United Kingdom
    • Oford University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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%

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all-cause mortality	Incidence of all-cause mortality at 30 days post index procedure	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	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.	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.	7-days post-index procedure or discharge (whichever occurs first)
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
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
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
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

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Won-Keun Kim, Dr, Kerckhoff-Klinik Forschungsgesellschaft mbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2019

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (ESTIMATE): December 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Aortic valve regurgitation; TAVI; Transfemoral access; Transcatheter Aortic Valve Implant
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: 2016-02 (Other Identifier: ap hm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No