Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
NCT ID: NCT05078619
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
466 participants
INTERVENTIONAL
2021-10-05
2029-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVI without routine PCI
Patients who are randomized to the experimental or index group undergo TAVI without routine PCI
No PCI
Omission of PCI of significant coronary artery disease prior to TAVI
TAVI with routine PCI
Patients who are randomized to the control or reference group undergo TAVI with routine PCI
No interventions assigned to this group
Interventions
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No PCI
Omission of PCI of significant coronary artery disease prior to TAVI
Eligibility Criteria
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Inclusion Criteria
* TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
* ≥ 1 stenosis in epicardial coronary artery (\> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
* Written informed consent.
Exclusion Criteria
* No PCI-eligible stenosis
* Contraindication for DAPT
* Life expectancy \< 1 year
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
UMC Utrecht
OTHER
Responsible Party
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Michiel Voskuil, MD, PhD
Professor in Cardiology
Principal Investigators
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Michiel Voskuil, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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RadboudUMC
Nijmegen, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Amphia Ziekenhuis Breda
Breda, North Brabant, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
UMC Groningen
Groningen, Provincie Groningen, Netherlands
Haga Ziekenhuis Den Haag
The Hague, South Holland, Netherlands
Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands
UMC Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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Aarts HM, Hemelrijk KI, Broeze GM, van Ginkel DJ, Versteeg GAA, Overduin DC, Tijssen JG, Beijk MAM, Baan J, Vis MM, Lemkes JS, de Winter RJ, Dickinson MG, Kraaijeveld AO, Mokhles MM, Dessing TC, Grundeken MJ, Claessen BEPM, Tonino PAL, Schotborgh CE, Meuwissen M, van Houwelingen GK, Wykrzykowska JJ, Amoroso G, Vossenberg TN, Vriesendorp PA, van Royen N, Ten Berg JM, Delewi R, Voskuil M. Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial. Am Heart J. 2025 Mar;281:133-139. doi: 10.1016/j.ahj.2024.12.003. Epub 2024 Dec 16.
Other Identifiers
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NL77915.041.21
Identifier Type: -
Identifier Source: org_study_id