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Active, not recruitingNCT05078619PRO-TAVIUpdated Dec 16, 2024

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

An interventional study of No PCI in Valvular Heart Disease, Aortic Valve Stenosis and Coronary Artery Disease, sponsored by UMC Utrecht. Active, not recruiting at 12 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
466
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.

02

Conditions studied

  • Valvular Heart Disease
  • Aortic Valve Stenosis
  • Coronary Artery Disease

Keywords

  • Transcatheter aortic valve implantation
  • Percutaneous coronary intervention
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 466 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
  • 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

Exclusion Criteria:

  • Unprotected LM-stenosis or equivalent
  • No PCI-eligible stenosis
  • Contraindication for DAPT
  • Life expectancy \< 1 year
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
466 participants (actual)

Study arms

  • Experimental
    TAVI without routine PCI

    Patients who are randomized to the experimental or index group undergo TAVI without routine PCI

    Procedure: No PCI

  • No intervention
    TAVI with routine PCI

    Patients who are randomized to the control or reference group undergo TAVI with routine PCI

Interventions

  • ProcedureNo PCI

    Omission of PCI of significant coronary artery disease prior to TAVI

06

What researchers measure

Primary outcomes

  1. composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria

    Time frame: 12 months from randomization

Secondary outcomes

  1. Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria

    Time frame: 4 months - 12 months - total follow up 5 years

  2. all-cause mortality

    VARC-3

    Time frame: 4 months - 12 months - total follow up 5 years

  3. myocardial infarction

    VARC-3

    Time frame: 4 months - 12 months - total follow up 5 years

  4. stroke

    VARC-3

    Time frame: 4 months - 12 months - total follow up 5 years

  5. VARC-3 bleeding

    Time frame: 4 months - 12 months - total follow up 5 years

  6. BARC bleeding

    BARC bleeding \> type 1

    Time frame: 4 months - 12 months - total follow up 5 years

  7. urgent and elective revascularization

    ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials \& ARC-2

    Time frame: 4 months - 12 months - total follow up 5 years

  8. Target lesion revascularization

    ARC-2

    Time frame: 4 months - 12 months - total follow up 5 years

  9. Target vessel revascularization

    ARC-2

    Time frame: 4 months - 12 months - total follow up 5 years

  10. rehospitalization

    VARC-3

    Time frame: 4 months - 12 months - total follow up 5 years

  11. Left ventricular function measured by echocardiography

    Time frame: 12 months

  12. Cost-effectiveness of omission of PCI using QALYs

    Time frame: 4 months - 12 months

  13. Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios

    Time frame: 4 months - 12 months

  14. Quality of life assessed by Euro Quality of Life 5D Questionnaire

    the system produces a 5-digit health status profile to describe quality of life in a descriptive manner. Therefore, no lowest and highest value can be stated.

    Time frame: 4 months - 12 months

  15. Quality of life assessed by SF-36 Questionnaire

    Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.

    Time frame: 4 months - 12 months

  16. Anginal status (CCS)

    Time frame: 4 months - 12 months

  17. NYHA classification

    Time frame: 4 months - 12 months

  18. Acute kidney injury stage 3 and 4

    VARC-3

    Time frame: 4 months - 12 months - total follow up 5 years

07

Study locations

12 sites
  • Medisch Centrum Leeuwarden
    Leeuwarden, Friesland, Netherlands
  • RadboudUMC
    Nijmegen, Gelderland, Netherlands
  • Maastricht UMC+
    Maastricht, Limburg, Netherlands
  • Amphia Ziekenhuis Breda
    Breda, Noord-Brabant, Netherlands
  • Catharina Ziekenhuis Eindhoven
    Eindhoven, Noord-Brabant, Netherlands
  • Amsterdam UMC
    Amsterdam, Noord-Holland, Netherlands
  • OLVG
    Amsterdam, Noord-Holland, Netherlands
  • Medisch Spectrum Twente
    Enschede, Overijssel, Netherlands
  • Antonius Ziekenhuis Nieuwegein
    Nieuwegein, Utrecht, Netherlands
  • Haga Ziekenhuis Den Haag
    Den Haag, Zuid-Holland, Netherlands
  • UMC Groningen
    Groningen, Netherlands
  • UMC Utrecht
    Utrecht, 3508GA, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05078619
Lead sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Responsible party
Michiel Voskuil, MD, PhD (Professor in Cardiology, UMC Utrecht) — Principal investigator
First posted
Oct 14, 2021
Start date
Oct 5, 2021
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Dec 16, 2024

Study contacts

Michiel Voskuil, MD PhD
principal investigator · UMC Utrecht

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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