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Active, Not Recruiting

NCT Number: NCT05078619

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Valvular Heart Disease Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RadboudUMC, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

No PCI

Procedure

Omission of PCI of significant coronary artery disease prior to TAVI

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

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

    VARC-3

  3. myocardial infarction

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

    VARC-3

  4. stroke

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

    VARC-3

  5. VARC-3 bleeding

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

  6. BARC bleeding

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

    BARC bleeding > type 1

  7. urgent and elective revascularization

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

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

  8. Target lesion revascularization

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

    ARC-2

  9. Target vessel revascularization

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

    ARC-2

  10. rehospitalization

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

    VARC-3

  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

    Time frame: 4 months - 12 months

    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.

  15. Quality of life assessed by SF-36 Questionnaire

    Time frame: 4 months - 12 months

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

  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

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

    VARC-3

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: PRO-TAVI

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Oct 14, 2021
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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