Clinical trial NCT05539573: PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
Official title: PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Stenosis
Keywords: Transcatheter aortic valve implantation (TAVI)
ACURATE neo2™ bioprosthetic aortic valve
ACURATE neo2™ transfemoral delivery system
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: National University of Ireland, Galway
First posted: 2022-09-14
Enrollment: 1043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to all-cause death
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mortality (count)
timeFrame: through study completion, an average of 1 year
measure: Mortality (rate)
timeFrame: through study completion, an average of 1 year
measure: Neurological events (count)
timeFrame: through study completion, an average of 1 year
measure: Neurological events (rate)
timeFrame: through study completion, an average of 1 year
measure: Myocardial infarction (count)
timeFrame: through study completion, an average of 1 year
measure: Myocardial infarction (rate)
timeFrame: through study completion, an average of 1 year
measure: Re-hospitalization (count)
timeFrame: through study completion, an average of 1 year
measure: Re-hospitalization (cumulative incidence)
timeFrame: through study completion, an average of 1 year
measure: Bleeding events (count)
timeFrame: through study completion, an average of 1 year
measure: Bleeding events (rate)
timeFrame: through study completion, an average of 1 year
measure: Transfusions
timeFrame: through study completion, an average of 1 year
measure: Vascular and access-related complications (count)
timeFrame: through study completion, an average of 1 year
measure: Vascular and access-related complications (rate)
timeFrame: through study completion, an average of 1 year
measure: Cardiac structural complications (count)
timeFrame: through study completion, an average of 1 year
measure: Cardiac structural complications (rate)
timeFrame: through study completion, an average of 1 year
measure: Other acute procedural and technical valve related complications (count)
timeFrame: through study completion, an average of 1 year
measure: Other acute procedural and technical valve related complications (rate)
timeFrame: through study completion, an average of 1 year
measure: Conduction disturbances and arrhythmia (count)
timeFrame: through study completion, an average of 1 year
measure: Conduction disturbances and arrhythmia (rate)
timeFrame: through study completion, an average of 1 year
measure: Acute kidney injury (count)
timeFrame: through study completion, an average of 1 year
measure: Acute kidney injury (rate)
timeFrame: through study completion, an average of 1 year
measure: Bioprosthetic valve dysfunction (count)
timeFrame: through study completion, an average of 1 year
measure: Bioprosthetic valve dysfunction (rate)
timeFrame: through study completion, an average of 1 year
measure: Clinically significant valve thrombosis (count)
timeFrame: through study completion, an average of 1 year
measure: Clinically significant valve thrombosis (rate)
timeFrame: through study completion, an average of 1 year
measure: Patient-reported outcomes and health status
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Composite endpoint: technical success
timeFrame: at exit from procedure room
measure: Composite endpoint: device success
timeFrame: at 30 days post procedure
measure: Early safety
timeFrame: at 30 days post procedure
measure: Clinical efficacy
timeFrame: at 12 months post procedure
Locations:
city: Massy
country: France
facility: Jacques Cartier Private Hospital Massy
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord Saint-Denis
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön Klinikum, Campus Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Bad Krozingen
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Heart Center Leipzig at Leipzig University
city: München
country: Germany
facility: Augustinum
city: München
country: Germany
facility: Deutsches Herzzentrum
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: Regensburg
country: Germany
facility: Uniklinikum Regensburg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Lund
country: Sweden
facility: Lund University
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Leipzig University
name: Holger Thiele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: