- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05539573
PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis (PROVE)
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
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Holger Thiele, Prof. Dr.
- Phone Number: 1428 + 49 341 865
- Email: holger.thiele@medizin.uni-leipzig.de
Study Contact Backup
- Name: Mohamed Abdel-Wahab, Prof. Dr.
- Phone Number: 1428 + 49 341 865
- Email: mohamed.abdel-wahab@medizin.uni-leipzig.de
Study Locations
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Massy, France
- Recruiting
- Jacques Cartier Private Hospital Massy
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Contact:
- Stephane Champagne, Dr.
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Saint-Denis, France
- Recruiting
- Centre Cardiologique du Nord Saint-Denis
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Contact:
- Mohammed Nejjari, Dr.
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Augsburg, Germany
- Recruiting
- Universitätsklinikum Augsburg
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Contact:
- Sebastien Elvinger, Dr.
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Bad Berka, Germany
- Recruiting
- Zentralklinik Bad Berka GmbH
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Contact:
- Philipp Lauten, Dr.
- Phone Number: +49 36458 541206
- Email: philipp.lauten@zentralklinik.de
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Bad Nauheim, Germany
- Recruiting
- Kerckhoff-Klinik GmbH
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Contact:
- Won-Keun Kim, Dr.
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Bad Neustadt An Der Saale, Germany
- Recruiting
- Rhön Klinikum, Campus Bad Neustadt
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Contact:
- Wilko Reents, PD Dr.
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Bad Oeynhausen, Germany
- Recruiting
- Herz- und Diabeteszentrum NRW
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Contact:
- Tanja Rudolph, Prof. Dr.
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Bad Rothenfelde, Germany
- Recruiting
- Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
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Contact:
- Nico Doll, Prof
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Berlin, Germany
- Recruiting
- Deutsches Herzzentrum der Charité
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Contact:
- Christoph Klein, PD Dr.
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Contact:
- Axel Unbehaun, PD Dr.
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Dortmund, Germany
- Recruiting
- St. Johannes Hospital
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Contact:
- Helge Möllmann, Prof. Dr.
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Dresden, Germany
- Recruiting
- Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
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Contact:
- Norman Mangner, Prof. Dr.
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Düsseldorf, Germany
- Recruiting
- Universitätsklinikum Düsseldorf
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Contact:
- Tobias Zeus, Dr.
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Essen, Germany
- Recruiting
- Elisabeth-Krankenhaus
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Contact:
- Thorsten Schmitz, Dr.
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Frankfurt, Germany
- Recruiting
- Universitatsklinikum Frankfurt
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Contact:
- Thomas Walther, Prof. Dr.
- Phone Number: +49 69 6301-6142
- Email: thomas.walther@kgu.de
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Freiburg, Germany
- Recruiting
- Universitätsklinikum Freiburg - Bad Krozingen
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Contact:
- Jürgen Rothe, Dr.
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Hamburg, Germany
- Recruiting
- Universitäres Herz- und Gefäßzentrum Hamburg
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Contact:
- Andreas Schäfer, PD Dr.
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Köln, Germany
- Recruiting
- Universitätsklinikum Köln
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Contact:
- Matti Adam, Dr.
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Leipzig, Germany
- Recruiting
- Heart Center Leipzig at Leipzig University
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Contact:
- Holger Thiele, Prof. Dr.
- Phone Number: 1428 + 49 341 865
- Email: holger.thiele@medizin.uni-leipzig.de
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Contact:
- Mohamed Abdel-Wahab, Prof. Dr.
- Phone Number: 1428 + 49 341 865
- Email: mohamed.abdel-wahab@medizin.uni-leipzig.de
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München, Germany
- Recruiting
- Augustinum
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Contact:
- Oliver Husser, Prof. Dr.
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München, Germany
- Recruiting
- Deutsches Herzzentrum
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Contact:
- Michael Joner, Prof. Dr.
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München, Germany
- Recruiting
- LMU Klinikum der Universität München
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Contact:
- Steffen Massberg, Prof
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Regensburg, Germany
- Recruiting
- Uniklinikum Regensburg
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Contact:
- Michael Hilker, Prof. Dr.
- Phone Number: +49 941 944-9805
- Email: Michael.Hilker@ukr.de
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Tübingen, Germany
- Recruiting
- Universitatsklinikum Tubingen
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Contact:
- Tobias Geisler, Prof. Dr.
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Lund, Sweden
- Not yet recruiting
- Lund University
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Contact:
- Mathias Götberg, MD, PhD
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Basel, Switzerland
- Recruiting
- Universitatsspital Basel
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Contact:
- Thomas Nestelberger, Dr.
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Luzern, Switzerland
- Recruiting
- Luzerner Kantonsspital
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Contact:
- Stefan Toggweiler, Prof. Dr.
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Zürich, Switzerland
- Recruiting
- Universitatsspital Zurich
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Contact:
- Jonathan Michel, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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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:
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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
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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.
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through study completion, an average of 1 year
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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
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through study completion, an average of 1 year
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Mortality (rate)
Time Frame: through study completion, an average of 1 year
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Rates, by cause and timing period
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through study completion, an average of 1 year
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Neurological events (count)
Time Frame: through study completion, an average of 1 year
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Numbers by type, grading and timing
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through study completion, an average of 1 year
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Neurological events (rate)
Time Frame: through study completion, an average of 1 year
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Rates by type, grading and timing
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through study completion, an average of 1 year
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Myocardial infarction (count)
Time Frame: through study completion, an average of 1 year
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Numbers by type
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through study completion, an average of 1 year
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Myocardial infarction (rate)
Time Frame: through study completion, an average of 1 year
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Rates, by type
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through study completion, an average of 1 year
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Re-hospitalization (count)
Time Frame: through study completion, an average of 1 year
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Re-hospitalization yes/no: numbers -> Total number of re-hospitalization per patient, by type
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through study completion, an average of 1 year
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Re-hospitalization (cumulative incidence)
Time Frame: through study completion, an average of 1 year
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Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type
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through study completion, an average of 1 year
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Bleeding events (count)
Time Frame: through study completion, an average of 1 year
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Numbers by type
|
through study completion, an average of 1 year
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Bleeding events (rate)
Time Frame: through study completion, an average of 1 year
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Rates by type
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through study completion, an average of 1 year
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Transfusions
Time Frame: through study completion, an average of 1 year
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Total number per patient, by timing period
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through study completion, an average of 1 year
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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
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Vascular and access-related complications (rate)
Time Frame: through study completion, an average of 1 year
|
Rates by type and severity
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through study completion, an average of 1 year
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Cardiac structural complications (count)
Time Frame: through study completion, an average of 1 year
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Numbers by severity
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through study completion, an average of 1 year
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Cardiac structural complications (rate)
Time Frame: through study completion, an average of 1 year
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Rates by severity
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through study completion, an average of 1 year
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Other acute procedural and technical valve related complications (count)
Time Frame: through study completion, an average of 1 year
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Numbers by category and type of clinical presentation
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through study completion, an average of 1 year
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Other acute procedural and technical valve related complications (rate)
Time Frame: through study completion, an average of 1 year
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Rates by category and type of clinical presentation
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through study completion, an average of 1 year
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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
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Conduction disturbances and arrhythmia (rate)
Time Frame: through study completion, an average of 1 year
|
Rates by type, timing and duration
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through study completion, an average of 1 year
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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
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Acute kidney injury (rate)
Time Frame: through study completion, an average of 1 year
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Rates by stage
|
through study completion, an average of 1 year
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Bioprosthetic valve dysfunction (count)
Time Frame: through study completion, an average of 1 year
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Numbers by type
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through study completion, an average of 1 year
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Bioprosthetic valve dysfunction (rate)
Time Frame: through study completion, an average of 1 year
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Rates by type
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through study completion, an average of 1 year
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Clinically significant valve thrombosis (count)
Time Frame: through study completion, an average of 1 year
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Numbers by timing period
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through study completion, an average of 1 year
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Clinically significant valve thrombosis (rate)
Time Frame: through study completion, an average of 1 year
|
Rates by timing period
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through study completion, an average of 1 year
|
Patient-reported outcomes and health status
Time Frame: through study completion, an average of 1 year
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Kansas City Cardiomyopathy Questionnaire (KCCQ)
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through study completion, an average of 1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite endpoint: technical success
Time Frame: at exit from procedure room
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According to Valve Academic Research Consortium (VARC)-3 criteria
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at exit from procedure room
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Composite endpoint: device success
Time Frame: at 30 days post procedure
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According to VARC-3 criteria
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at 30 days post procedure
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Early safety
Time Frame: at 30 days post procedure
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Determined at 30 days post procedure
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at 30 days post procedure
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Clinical efficacy
Time Frame: at 12 months post procedure
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Determined at 12 months post procedure
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at 12 months post procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Holger Thiele, Prof. Dr., Leipzig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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