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Valvular Heart DiseasePRO-TAVINCT05078619

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

A study testing No PCI in people with Valvular Heart Disease and Aortic Valve Stenosis, run by UMC Utrecht at 12 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
No PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
12 sitesNetherlands
Study dates
5 Oct 2021to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Netherlands12 sites

  • Amsterdam UMC

    Amsterdam, North Holland

  • OLVG

    Amsterdam, North Holland

  • Amphia Ziekenhuis Breda

    Breda, North Brabant

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, North Brabant

  • Medisch Spectrum Twente

    Enschede, Overijssel

  • UMC Groningen

    Groningen, Provincie Groningen

  • Medisch Centrum Leeuwarden

    Leeuwarden, Provincie Friesland

  • Maastricht UMC+

    Maastricht, Limburg

  • Antonius Ziekenhuis Nieuwegein

    Nieuwegein, Utrecht

  • RadboudUMC

    Nijmegen, Gelderland

  • Haga Ziekenhuis Den Haag

    The Hague, South Holland

  • UMC Utrecht

    Utrecht, Utrecht, 3508GA

Other trials in Netherlands

About this study

Official title: Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial

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.

Being tested
No PCI
Keywords
Transcatheter aortic valve implantation, Percutaneous coronary intervention
Medical subject headings
Heart Valve Diseases, Aortic Valve Stenosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No PCIProcedure or surgery

    Omission of PCI of significant coronary artery disease prior to TAVI

Study groups in NCT05078619
Study groupRoleWhat they receive
TAVI without routine PCIExperimentalPatients who are randomized to the experimental or index group undergo TAVI without routine PCI
Receives: Procedure: No PCI
TAVI with routine PCINo interventionPatients who are randomized to the control or reference group undergo TAVI with routine PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months from randomization

Secondary outcomes (18)

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

    Measured: 4 months - 12 months - total follow up 5 years

  2. all-cause mortality

    VARC-3

    Measured: 4 months - 12 months - total follow up 5 years

  3. myocardial infarction

    VARC-3

    Measured: 4 months - 12 months - total follow up 5 years

  4. stroke

    VARC-3

    Measured: 4 months - 12 months - total follow up 5 years

  5. VARC-3 bleeding

    Measured: 4 months - 12 months - total follow up 5 years

  6. BARC bleeding

    BARC bleeding > type 1

    Measured: 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

    Measured: 4 months - 12 months - total follow up 5 years

  8. Target lesion revascularization

    ARC-2

    Measured: 4 months - 12 months - total follow up 5 years

  9. Target vessel revascularization

    ARC-2

    Measured: 4 months - 12 months - total follow up 5 years

  10. rehospitalization

    VARC-3

    Measured: 4 months - 12 months - total follow up 5 years

  11. Left ventricular function measured by echocardiography

    Measured: 12 months

  12. Cost-effectiveness of omission of PCI using QALYs

    Measured: 4 months - 12 months

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

    Measured: 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.

    Measured: 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.

    Measured: 4 months - 12 months

  16. Anginal status (CCS)

    Measured: 4 months - 12 months

  17. NYHA classification

    Measured: 4 months - 12 months

  18. Acute kidney injury stage 3 and 4

    VARC-3

    Measured: 4 months - 12 months - total follow up 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start5 Oct 2021
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05078619
Sponsor's protocol ID
NL77915.041.21
Acronym
PRO-TAVI
Status last verified
Dec 2024
First submitted
21 Sep 2021
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Broeze GM, Aarts HM, da Silva Voorham J, Hemelrijk KI, Jan van Ginkel D, Versteeg GAA, 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, Tijssen JGP, Voskuil M, Delewi R; PRO-TAVI Investigators. Impact of Extent of Coronary Artery Disease in Transcatheter Aortic Valve Replacement: A PRO-TAVI Substudy. JACC Cardiovasc Interv. 2026 Oct 12;19(19):2619-2630. doi: 10.1016/j.jcin.2026.07.034.

    PubMed 42863875

  • Delewi R, Aarts HM, Broeze GM, Hemelrijk KI, van Ginkel DJ, Versteeg GAA, 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, Tijssen JGP, Voskuil M; PRO-TAVI trial investigators. Deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (PRO-TAVI): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial. Lancet. 2026 Apr 11;407(10537):1429-1438. doi: 10.1016/S0140-6736(26)00308-9. Epub 2026 Mar 29.

    PubMed 41921523

  • 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.

    PubMed 39674524

Questions about this trial

What is this clinical trial studying?

A study testing No PCI in people with Valvular Heart Disease and Aortic Valve Stenosis, run by UMC Utrecht at 12 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05078619, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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