Clinical trial NCT02987894: PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
Official title: Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: TAVI
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Implant
Transfemoral access
Aortic valve regurgitation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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%

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total aortic regurgitation over time.
timeFrame: 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:
measure: Incidence of all-cause mortality
timeFrame: 30 days post-index procedure
measure: Clinical events as defined per VARC-2 consensus document (VARC-2)
timeFrame: Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
measure: Number of patients with procedural success according to VARC II criteria
timeFrame: at index- Procedure
measure: Number of patients with device success
timeFrame: 7-days post-index procedure or discharge (whichever occurs first)
measure: Number of patients with adverse events assessed by VARC-2 Composite Safety
timeFrame: 30 days post-index procedure
measure: Functional improvement
timeFrame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
measure: Hemodynamic function improvement from baseline
timeFrame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
measure: Valve related dysfunction
timeFrame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Vancouver
country: Canada
facility: Saint Paul's Hospital, Porvidence Health Care Institute
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Nauheim
country: Germany
facility: Kerkhoff Kilnik
city: Bernau
country: Germany
facility: Immanuel Hospital Bernau- Herzzentrum Brandenburg
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus GmbH
city: Dortmund
country: Germany
facility: St Johannes Hospital
city: Frankfurt
country: Germany
facility: Goethe Universität
city: Giessen
country: Germany
facility: Universitätklinikum Giessen
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: Städisches Klinikum Karlsruhe GmbH
city: Karlsruhe
country: Germany
facility: Helios Klinik Fur Herzzchirurgie Karlsruhe
city: Köln
country: Germany
facility: Universitätsklinikum
city: Leipzig
country: Germany
facility: Sana Herzzentrum Leipzig
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Neuss
country: Germany
facility: Städische Kliniken
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
city: Massa
country: Italy
facility: Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci
city: Leicester
country: United Kingdom
facility: University Hospital NHS
city: Oxford
country: United Kingdom
facility: Oford University Hospital
Study officials:
affiliation: Kerckhoff-Klinik Forschungsgesellschaft mbH
name: Won-Keun Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References: