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

February 8, 2024 updated by: Holger Thiele, University of Leipzig

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).

Study Overview

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Massy, France
        • Recruiting
        • Jacques Cartier Private Hospital Massy
        • Contact:
          • Stephane Champagne, Dr.
      • Saint-Denis, France
        • Recruiting
        • Centre Cardiologique du Nord Saint-Denis
        • Contact:
          • Mohammed Nejjari, Dr.
      • Augsburg, Germany
        • Recruiting
        • Universitätsklinikum Augsburg
        • Contact:
          • Sebastien Elvinger, Dr.
      • Bad Berka, Germany
      • Bad Nauheim, Germany
        • Recruiting
        • Kerckhoff-Klinik GmbH
        • Contact:
          • Won-Keun Kim, Dr.
      • Bad Neustadt An Der Saale, Germany
        • Recruiting
        • Rhön Klinikum, Campus Bad Neustadt
        • Contact:
          • Wilko Reents, PD Dr.
      • Bad Oeynhausen, Germany
        • Recruiting
        • Herz- und Diabeteszentrum NRW
        • Contact:
          • Tanja Rudolph, Prof. Dr.
      • Bad Rothenfelde, Germany
        • Recruiting
        • Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
        • Contact:
          • Nico Doll, Prof
      • Berlin, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Contact:
          • Christoph Klein, PD Dr.
        • Contact:
          • Axel Unbehaun, PD Dr.
      • Dortmund, Germany
        • Recruiting
        • St. Johannes Hospital
        • Contact:
          • Helge Möllmann, Prof. Dr.
      • Dresden, Germany
        • Recruiting
        • Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
        • Contact:
          • Norman Mangner, Prof. Dr.
      • Düsseldorf, Germany
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Tobias Zeus, Dr.
      • Essen, Germany
        • Recruiting
        • Elisabeth-Krankenhaus
        • Contact:
          • Thorsten Schmitz, Dr.
      • Frankfurt, Germany
        • Recruiting
        • Universitatsklinikum Frankfurt
        • Contact:
      • Freiburg, Germany
        • Recruiting
        • Universitätsklinikum Freiburg - Bad Krozingen
        • Contact:
          • Jürgen Rothe, Dr.
      • Hamburg, Germany
        • Recruiting
        • Universitäres Herz- und Gefäßzentrum Hamburg
        • Contact:
          • Andreas Schäfer, PD Dr.
      • Köln, Germany
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:
          • Matti Adam, Dr.
      • Leipzig, Germany
      • München, Germany
        • Recruiting
        • Augustinum
        • Contact:
          • Oliver Husser, Prof. Dr.
      • München, Germany
        • Recruiting
        • Deutsches Herzzentrum
        • Contact:
          • Michael Joner, Prof. Dr.
      • München, Germany
        • Recruiting
        • LMU Klinikum der Universität München
        • Contact:
          • Steffen Massberg, Prof
      • Regensburg, Germany
        • Recruiting
        • Uniklinikum Regensburg
        • Contact:
      • Tübingen, Germany
        • Recruiting
        • Universitatsklinikum Tubingen
        • Contact:
          • Tobias Geisler, Prof. Dr.
      • Lund, Sweden
        • Not yet recruiting
        • Lund University
        • Contact:
          • Mathias Götberg, MD, PhD
      • Basel, Switzerland
        • Recruiting
        • Universitatsspital Basel
        • Contact:
          • Thomas Nestelberger, Dr.
      • Luzern, Switzerland
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
          • Stefan Toggweiler, Prof. Dr.
      • Zürich, Switzerland
        • Recruiting
        • Universitatsspital Zurich
        • Contact:
          • Jonathan Michel, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
Patients with planned transcatheter treatment of severe aortic stenosis 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality (count)
Time Frame: through study completion, an average of 1 year
Numbers by cause and timing period
through study completion, an average of 1 year
Mortality (rate)
Time Frame: through study completion, an average of 1 year
Rates, by cause and timing period
through study completion, an average of 1 year
Neurological events (count)
Time Frame: through study completion, an average of 1 year
Numbers by type, grading and timing
through study completion, an average of 1 year
Neurological events (rate)
Time Frame: through study completion, an average of 1 year
Rates by type, grading and timing
through study completion, an average of 1 year
Myocardial infarction (count)
Time Frame: through study completion, an average of 1 year
Numbers by type
through study completion, an average of 1 year
Myocardial infarction (rate)
Time Frame: through study completion, an average of 1 year
Rates, by type
through study completion, an average of 1 year
Re-hospitalization (count)
Time Frame: through study completion, an average of 1 year
Re-hospitalization yes/no: numbers -> Total number of re-hospitalization per patient, by type
through study completion, an average of 1 year
Re-hospitalization (cumulative incidence)
Time Frame: through study completion, an average of 1 year
Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type
through study completion, an average of 1 year
Bleeding events (count)
Time Frame: through study completion, an average of 1 year
Numbers by type
through study completion, an average of 1 year
Bleeding events (rate)
Time Frame: through study completion, an average of 1 year
Rates by type
through study completion, an average of 1 year
Transfusions
Time Frame: through study completion, an average of 1 year
Total number per patient, by timing period
through study completion, an average of 1 year
Vascular and access-related complications (count)
Time Frame: through study completion, an average of 1 year
Numbers by type and severity
through study completion, an average of 1 year
Vascular and access-related complications (rate)
Time Frame: through study completion, an average of 1 year
Rates by type and severity
through study completion, an average of 1 year
Cardiac structural complications (count)
Time Frame: through study completion, an average of 1 year
Numbers by severity
through study completion, an average of 1 year
Cardiac structural complications (rate)
Time Frame: through study completion, an average of 1 year
Rates by severity
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
Numbers by category and type of clinical presentation
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
Rates by category and type of clinical presentation
through study completion, an average of 1 year
Conduction disturbances and arrhythmia (count)
Time Frame: through study completion, an average of 1 year
Numbers by type, timing and duration
through study completion, an average of 1 year
Conduction disturbances and arrhythmia (rate)
Time Frame: through study completion, an average of 1 year
Rates by type, timing and duration
through study completion, an average of 1 year
Acute kidney injury (count)
Time Frame: through study completion, an average of 1 year
Numbers by stage
through study completion, an average of 1 year
Acute kidney injury (rate)
Time Frame: through study completion, an average of 1 year
Rates by stage
through study completion, an average of 1 year
Bioprosthetic valve dysfunction (count)
Time Frame: through study completion, an average of 1 year
Numbers by type
through study completion, an average of 1 year
Bioprosthetic valve dysfunction (rate)
Time Frame: through study completion, an average of 1 year
Rates by type
through study completion, an average of 1 year
Clinically significant valve thrombosis (count)
Time Frame: through study completion, an average of 1 year
Numbers by timing period
through study completion, an average of 1 year
Clinically significant valve thrombosis (rate)
Time Frame: through study completion, an average of 1 year
Rates by timing period
through study completion, an average of 1 year
Patient-reported outcomes and health status
Time Frame: through study completion, an average of 1 year
Kansas City Cardiomyopathy Questionnaire (KCCQ)
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint: technical success
Time Frame: at exit from procedure room
According to Valve Academic Research Consortium (VARC)-3 criteria
at exit from procedure room
Composite endpoint: device success
Time Frame: at 30 days post procedure
According to VARC-3 criteria
at 30 days post procedure
Early safety
Time Frame: at 30 days post procedure
Determined at 30 days post procedure
at 30 days post procedure
Clinical efficacy
Time Frame: at 12 months post procedure
Determined at 12 months post procedure
at 12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Holger Thiele, Prof. Dr., Leipzig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Stenosis

Clinical Trials on Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.

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