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Active, Not Recruiting

NCT Number: NCT03058627

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
  • At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Exclusion criteria

  • Life expectancy < 1 year due to other severe non-cardiac disease
  • Severe renal failure with estimated glomerular filtration rate < 20 ml/min
  • No PCI-eligible coronary artery stenosis, but rotablation is allowed
  • Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
  • Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
  • Only stenoses with thrombolysis in myocardial infarction grad < 3
  • Potential pregnancy
  • Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
  • More than one chronic total occlusion (CTO)

Treatment and study plan

PCI

Procedure

FFR guided PCI

Primary outcomes

  1. All-cause mortality, myocardial infarction, or urgent revascularization

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI

Secondary outcomes

  1. All cause mortality

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing all cause mortality

  2. Myocardial infarction

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing myocardial infarction

  3. Urgent revascularization

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing urgent revascularization

  4. All cause mortality or myocardial infarction

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing all cause mortality or myocardial infarction

  5. Cardiovascular mortality

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing cardiovascular mortality

  6. Cardiovascular mortality, myocardial infarction, or urgent PCI

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI

  7. Cardiovascular mortality or myocardial infarction

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing cardiovascular mortality or myocardial infarction

  8. Admission for new onset of heart failure

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing admission for new onset of heart failure

  9. Peri-procedural (PCI) myocardial infarction

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing peri-procedural (PCI) myocardial infarction

  10. Peri-procedural (TAVI) myocardial infarction

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing peri-procedural (TAVI) myocardial infarction

  11. Any revascularization

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing any revascularization

  12. Stroke or transient ischemic attack (TIA)

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing stroke or transient ischemic attack (TIA)

  13. Angina status (Seattle questionnaire), CCS and NYHA class

    Time frame: 30 days and 1 year

    Number of patients experiencing CCS and NYHA class

  14. Bleeding

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing bleeding

  15. Quality of Life

    Time frame: 30 days and 1 year

    Number of patients experiencing improvement in Quality of life

  16. Acute kidney injury

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing acute kidney injury

  17. Target vessel revascularization

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing target vessel revascularization

  18. Target lession revascularization

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing target lession revascularization

  19. Cost effectiveness analysis

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Cost effectiveness analysis

  20. Stent thrombosis

    Time frame: Until the last included patients have been followed for 1 year after the TAVI

    Number of patients experiencing stent thrombosis

Sponsors and collaborators

Lead sponsor

Thomas Engstrom

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Haukeland University Hospital
  • Helsinki University Central Hospital
  • Karolinska University Hospital
  • Lund University Hospital
  • Odense University Hospital
  • Oulu University Hospital
  • Pauls Stradins Clinical University Hospital
  • Rigshospitalet, Denmark
  • Sahlgrenska University Hospital
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Official study title

Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial

Acronym: NOTION-3

Important dates

Study start
2017
Primary completion
2024
Study completion
2027
First posted
Feb 23, 2017
Registry last updated
Dec 19, 2023

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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