Aortic StenosisPROGRESSNCT02987894
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
An observational study of Aortic Stenosis, run by Symetis SA at 23 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ACURATE neo™ Aortic Bioprosthesis
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 2 Jan 2017to Sep 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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%
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Germany17 sites
Klinikum Augsburg
Augsburg, 86156
Zentralklinik Bad Berka
Bad Berka, 99437
Kerkhoff Kilnik
Bad Nauheim, 61231
Immanuel Hospital Bernau- Herzzentrum Brandenburg
Bernau, 13321
Universitätsklinikum
Cologne, 50924
Sana-Herzzentrum Cottbus GmbH
Cottbus, 03048
St Johannes Hospital
Dortmund, 44137
Goethe Universität
Frankfurt, 60323
Universitätklinikum Giessen
Giessen, 35392
Universitätsklinikum Halle
Halle, 06097
Universitätsklinikum Jena
Jena, 07743
Städisches Klinikum Karlsruhe GmbH
Karlsruhe, 76133
Helios Klinik Fur Herzzchirurgie Karlsruhe
Karlsruhe, 76185
Sana Herzzentrum Leipzig
Leipzig, 04289
Universitätsklinikum Münster
Münster, 48149
Städische Kliniken
Neuss, 41464
Universitätsklinikum Tübingen
Tübingen, 72016
Canada2 sites
London Health Sciences Centre, University Hospital
London, Ontario
Saint Paul's Hospital, Porvidence Health Care Institute
Vancouver, BC V6Z 1Y6
Italy2 sites
Ospedale Civile di Legnano
Legnano
Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci
Massa, 54100
United Kingdom2 sites
University Hospital NHS
Leicester
Oford University Hospital
Oxford
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- ACURATE neo™ Aortic Bioprosthesis
- Keywords
- TAVI, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implant, Transfemoral access, Aortic valve regurgitation
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACURATE neo™ Aortic BioprosthesisDevice
Also called ACURATE TF™ Transfemoral Delivery System
TAVI, transcatheter aortic valve replacement. Transfemoral access.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total aortic regurgitation over time.
total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up
Measured: 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
Incidence of all-cause mortality at 30 days post index procedure
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 30 days post-index procedure
Functional improvement
Functional improvement from baseline as per NYHA Functional Classification
Measured: 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
Measured: 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)
Measured: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start2 Jan 2017
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won-Keun Kim, Dr, Principal investigator, Kerckhoff-Klinik Forschungsgesellschaft mbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987894
- Sponsor's protocol ID
- 2016-02
- Acronym
- PROGRESS
- Status last verified
- Apr 2020
- First submitted
- 27 Oct 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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).
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry
- ClinicalTrials.gov ID
- NCT02987894
- Acronym / sponsor ID
- PROGRESS / 2016-02
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implant, Transfemoral access, Aortic valve regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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%
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACURATE neo™ Aortic BioprosthesisAlso: ACURATE TF™ Transfemoral Delivery SystemTAVI, transcatheter aortic valve replacement. Transfemoral access. | Device | – |
Primary outcome
Change in total aortic regurgitation over time.
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
total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up
8 secondary outcomes
Incidence of all-cause mortality
Time frame: 30 days post-index procedure
Clinical events as defined per VARC-2 consensus document (VARC-2)
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
Time frame: at index- Procedure
Number of patients with device success
Time frame: 7-days post-index procedure or discharge (whichever occurs first)
Number of patients with adverse events assessed by VARC-2 Composite Safety
Time frame: 30 days post-index procedure
Functional improvement
Time frame: 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
Time frame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Valve related dysfunction
Time frame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: Undecided. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won-Keun Kim, Dr principal investigator
Kerckhoff-Klinik Forschungsgesellschaft mbH
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Symetis SA at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Canada, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total aortic regurgitation over time. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.