PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

Aortic Stenosis Clinical Trial

— PROVE  

Official title:

PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05539573
• Other study ID #: PROVE
• Status: Active, not recruiting
• Start date: October 4, 2022
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1043
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• 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: 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.

Locations

Country	Name	City	State
France	Jacques Cartier Private Hospital Massy	Massy
France	Centre Cardiologique du Nord Saint-Denis	Saint-Denis
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Rhön Klinikum, Campus Bad Neustadt	Bad Neustadt An Der Saale
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG	Bad Rothenfelde
Germany	Deutsches Herzzentrum der Charité	Berlin
Germany	St. Johannes Hospital	Dortmund
Germany	Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Elisabeth-Krankenhaus	Essen
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Universitätsklinikum Freiburg - Bad Krozingen	Freiburg
Germany	Universitäres Herz- und Gefäßzentrum Hamburg	Hamburg
Germany	Universitätsklinikum Köln	Köln
Germany	Heart Center Leipzig at Leipzig University	Leipzig
Germany	Augustinum	München
Germany	Deutsches Herzzentrum	München
Germany	LMU Klinikum der Universität München	München
Germany	Uniklinikum Regensburg	Regensburg
Germany	Universitätsklinikum Tübingen	Tübingen
Sweden	Lund University	Lund
Switzerland	Universitätsspital Basel	Basel
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	National University of Ireland, Galway

Countries where clinical trial is conducted

France,  Germany,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite endpoint: technical success	According to Valve Academic Research Consortium (VARC)-3 criteria	at exit from procedure room
Other	Composite endpoint: device success	According to VARC-3 criteria	at 30 days post procedure
Other	Early safety	Determined at 30 days post procedure	at 30 days post procedure
Other	Clinical efficacy	Determined at 12 months post procedure	at 12 months post procedure
Primary	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.	through study completion, an average of 1 year
Secondary	Mortality (count)	Numbers by cause and timing period	through study completion, an average of 1 year
Secondary	Mortality (rate)	Rates, by cause and timing period	through study completion, an average of 1 year
Secondary	Neurological events (count)	Numbers by type, grading and timing	through study completion, an average of 1 year
Secondary	Neurological events (rate)	Rates by type, grading and timing	through study completion, an average of 1 year
Secondary	Myocardial infarction (count)	Numbers by type	through study completion, an average of 1 year
Secondary	Myocardial infarction (rate)	Rates, by type	through study completion, an average of 1 year
Secondary	Re-hospitalization (count)	Re-hospitalization yes/no: numbers -> Total number of re-hospitalization per patient, by type	through study completion, an average of 1 year
Secondary	Re-hospitalization (cumulative incidence)	Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type	through study completion, an average of 1 year
Secondary	Bleeding events (count)	Numbers by type	through study completion, an average of 1 year
Secondary	Bleeding events (rate)	Rates by type	through study completion, an average of 1 year
Secondary	Transfusions	Total number per patient, by timing period	through study completion, an average of 1 year
Secondary	Vascular and access-related complications (count)	Numbers by type and severity	through study completion, an average of 1 year
Secondary	Vascular and access-related complications (rate)	Rates by type and severity	through study completion, an average of 1 year
Secondary	Cardiac structural complications (count)	Numbers by severity	through study completion, an average of 1 year
Secondary	Cardiac structural complications (rate)	Rates by severity	through study completion, an average of 1 year
Secondary	Other acute procedural and technical valve related complications (count)	Numbers by category and type of clinical presentation	through study completion, an average of 1 year
Secondary	Other acute procedural and technical valve related complications (rate)	Rates by category and type of clinical presentation	through study completion, an average of 1 year
Secondary	Conduction disturbances and arrhythmia (count)	Numbers by type, timing and duration	through study completion, an average of 1 year
Secondary	Conduction disturbances and arrhythmia (rate)	Rates by type, timing and duration	through study completion, an average of 1 year
Secondary	Acute kidney injury (count)	Numbers by stage	through study completion, an average of 1 year
Secondary	Acute kidney injury (rate)	Rates by stage	through study completion, an average of 1 year
Secondary	Bioprosthetic valve dysfunction (count)	Numbers by type	through study completion, an average of 1 year
Secondary	Bioprosthetic valve dysfunction (rate)	Rates by type	through study completion, an average of 1 year
Secondary	Clinically significant valve thrombosis (count)	Numbers by timing period	through study completion, an average of 1 year
Secondary	Clinically significant valve thrombosis (rate)	Rates by timing period	through study completion, an average of 1 year
Secondary	Patient-reported outcomes and health status	Kansas City Cardiomyopathy Questionnaire (KCCQ)	through study completion, an average of 1 year