Aortic StenosisPROVENCT05539573
PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
An observational study of Aortic Stenosis, run by University of Leipzig at 27 sites in 4 countries.
Trial summary
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Type of treatment
- Medical device
- How many people
- 1,043 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 4 Oct 2022to Apr 2025
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be recruited from primary care clinics. As the ACURATE neo2™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the instructions for use (IFU).
Who may be able to join
- Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Age ≥ 18 years of age
- Written informed consent by patient and/or legal representative
Who cannot join
- Patient is unlikely to be able or willing to follow the investigator's instructions during study participation.
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
- 3. Patients placed in an institution by official or court order
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
Germany21 sites
Universitätsklinikum Augsburg
Augsburg
Zentralklinik Bad Berka GmbH
Bad Berka
Kerckhoff-Klinik GmbH
Bad Nauheim
Rhön Klinikum, Campus Bad Neustadt
Bad Neustadt an der Saale
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
Bad Rothenfelde
Deutsches Herzzentrum der Charité
Berlin
Universitätsklinikum Köln
Cologne
St. Johannes Hospital
Dortmund
Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Dresden
Universitätsklinikum Düsseldorf
Düsseldorf
Elisabeth-Krankenhaus
Essen
Universitätsklinikum Frankfurt
Frankfurt
Universitätsklinikum Freiburg - Bad Krozingen
Freiburg im Breisgau
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg
Heart Center Leipzig at Leipzig University
Leipzig
Augustinum
München
Deutsches Herzzentrum
München
LMU Klinikum der Universität München
München
Uniklinikum Regensburg
Regensburg
Universitätsklinikum Tübingen
Tübingen
Switzerland3 sites
Universitätsspital Basel
Basel
Luzerner Kantonsspital
Lucerne
Universitätsspital Zürich
Zurich
France2 sites
Jacques Cartier Private Hospital Massy
Massy
Centre Cardiologique du Nord Saint-Denis
Saint-Denis
About this study
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation).
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).
Read the detailed description
There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process.
If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field.
For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting.
The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.
- Conditions
- Aortic Stenosis
- Being tested
- Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Keywords
- Transcatheter aortic valve implantation (TAVI), ACURATE neo2™ bioprosthetic aortic valve, ACURATE neo2™ transfemoral delivery system
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.Device
The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods:
- Screening period: from screening to enrollment if study criteria are met.
- Implantation procedure: immediately pre-implant to 24 hours post-procedure.
- Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients with planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. Receives: Device: Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause death
The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive.
Measured: through study completion, an average of 1 year
Secondary outcomes (26)
Mortality (count)
Numbers by cause and timing period
Measured: through study completion, an average of 1 year
Mortality (rate)
Rates, by cause and timing period
Measured: through study completion, an average of 1 year
Neurological events (count)
Numbers by type, grading and timing
Measured: through study completion, an average of 1 year
Neurological events (rate)
Rates by type, grading and timing
Measured: through study completion, an average of 1 year
Myocardial infarction (count)
Numbers by type
Measured: through study completion, an average of 1 year
Myocardial infarction (rate)
Rates, by type
Measured: through study completion, an average of 1 year
Re-hospitalization (count)
Re-hospitalization yes/no: numbers -> Total number of re-hospitalization per patient, by type
Measured: through study completion, an average of 1 year
Re-hospitalization (cumulative incidence)
Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type
Measured: through study completion, an average of 1 year
Bleeding events (count)
Numbers by type
Measured: through study completion, an average of 1 year
Bleeding events (rate)
Rates by type
Measured: through study completion, an average of 1 year
Transfusions
Total number per patient, by timing period
Measured: through study completion, an average of 1 year
Vascular and access-related complications (count)
Numbers by type and severity
Measured: through study completion, an average of 1 year
Vascular and access-related complications (rate)
Rates by type and severity
Measured: through study completion, an average of 1 year
Cardiac structural complications (count)
Numbers by severity
Measured: through study completion, an average of 1 year
Cardiac structural complications (rate)
Rates by severity
Measured: through study completion, an average of 1 year
Other acute procedural and technical valve related complications (count)
Numbers by category and type of clinical presentation
Measured: through study completion, an average of 1 year
Other acute procedural and technical valve related complications (rate)
Rates by category and type of clinical presentation
Measured: through study completion, an average of 1 year
Conduction disturbances and arrhythmia (count)
Numbers by type, timing and duration
Measured: through study completion, an average of 1 year
Conduction disturbances and arrhythmia (rate)
Rates by type, timing and duration
Measured: through study completion, an average of 1 year
Acute kidney injury (count)
Numbers by stage
Measured: through study completion, an average of 1 year
Acute kidney injury (rate)
Rates by stage
Measured: through study completion, an average of 1 year
Bioprosthetic valve dysfunction (count)
Numbers by type
Measured: through study completion, an average of 1 year
Bioprosthetic valve dysfunction (rate)
Rates by type
Measured: through study completion, an average of 1 year
Clinically significant valve thrombosis (count)
Numbers by timing period
Measured: through study completion, an average of 1 year
Clinically significant valve thrombosis (rate)
Rates by timing period
Measured: through study completion, an average of 1 year
Patient-reported outcomes and health status
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start4 Oct 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
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
- 1,043 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Responsible party
- Principal investigator, Holger Thiele, University of Leipzig
- Investigators
- Holger Thiele, Prof. Dr., Principal investigator, Leipzig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539573
- Sponsor's protocol ID
- PROVE
- Acronym
- PROVE
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05539573
- Acronym / sponsor ID
- PROVE / PROVE
- Conditions
- Aortic Stenosis
- Keywords
- Transcatheter aortic valve implantation (TAVI), ACURATE neo2™ bioprosthetic aortic valve, ACURATE neo2™ transfemoral delivery system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- 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.
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation).
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).
Detailed description
There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process.
If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field.
For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting.
The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.Patients with planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from primary care clinics. As the ACURATE neo2™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the instructions for use (IFU).
Key inclusion criteria (3 listed)
- Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Age ≥ 18 years of age
- Written informed consent by patient and/or legal representative
Key exclusion criteria (3 listed)
- Patient is unlikely to be able or willing to follow the investigator's instructions during study participation.
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
- 3. Patients placed in an institution by official or court order
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 |
|---|---|---|
| Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods: 1. Screening period: from screening to enrollment if study criteria are met. 2. Implantation procedure: immediately pre-implant to 24 hours post-procedure. 3. Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure. | Device | Treatment |
Primary outcome
Time to all-cause death
Time frame: through study completion, an average of 1 year
The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive.
26 secondary outcomes
Mortality (count)
Time frame: through study completion, an average of 1 year
Mortality (rate)
Time frame: through study completion, an average of 1 year
Neurological events (count)
Time frame: through study completion, an average of 1 year
Neurological events (rate)
Time frame: through study completion, an average of 1 year
Myocardial infarction (count)
Time frame: through study completion, an average of 1 year
Myocardial infarction (rate)
Time frame: through study completion, an average of 1 year
Re-hospitalization (count)
Time frame: through study completion, an average of 1 year
Re-hospitalization (cumulative incidence)
Time frame: through study completion, an average of 1 year
Bleeding events (count)
Time frame: through study completion, an average of 1 year
Bleeding events (rate)
Time frame: through study completion, an average of 1 year
Transfusions
Time frame: through study completion, an average of 1 year
Vascular and access-related complications (count)
Time frame: through study completion, an average of 1 year
Vascular and access-related complications (rate)
Time frame: through study completion, an average of 1 year
Cardiac structural complications (count)
Time frame: through study completion, an average of 1 year
Cardiac structural complications (rate)
Time frame: through study completion, an average of 1 year
Other acute procedural and technical valve related complications (count)
Time frame: through study completion, an average of 1 year
Other acute procedural and technical valve related complications (rate)
Time frame: through study completion, an average of 1 year
Conduction disturbances and arrhythmia (count)
Time frame: through study completion, an average of 1 year
Conduction disturbances and arrhythmia (rate)
Time frame: through study completion, an average of 1 year
Acute kidney injury (count)
Time frame: through study completion, an average of 1 year
Acute kidney injury (rate)
Time frame: through study completion, an average of 1 year
Bioprosthetic valve dysfunction (count)
Time frame: through study completion, an average of 1 year
Bioprosthetic valve dysfunction (rate)
Time frame: through study completion, an average of 1 year
Clinically significant valve thrombosis (count)
Time frame: through study completion, an average of 1 year
Clinically significant valve thrombosis (rate)
Time frame: through study completion, an average of 1 year
Patient-reported outcomes and health status
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Holger Thiele, Prof. Dr. principal investigator
Leipzig University
27 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 University of Leipzig at 27 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 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, Switzerland, France, Sweden. 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?
Results are not available in the source record.
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?
Time to all-cause death (time frame: through study completion, an average of 1 year). 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 10 Apr 2024.