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Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation (NOTION-3)

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ClinicalTrials.gov Identifier: NCT03058627
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 27, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Lund University Hospital
Karolinska University Hospital
Rikshospitalet University Hospital
Haukeland University Hospital
Helsinki University Central Hospital
Tampere University Hospital
Oulu University Hospital
Turku University Hospital
Kuopio University Hospital
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Aortic Valve Stenosis TAVI PCI Procedure: PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2027


Arm Intervention/treatment
No Intervention: TAVI only
TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
Experimental: TAVI + FFR-guided complete revascularization
TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR < 0.80 in vessels ≥ 2.5 mm in diameter .
Procedure: PCI
FFR guided PCI




Primary Outcome Measures :
  1. All-cause mortality, myocardial infarction, or urgent revascularization [ Time Frame: 1 year ]
    Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 1 year ]
    Number of patients experiencing all cause mortality

  2. Myocardial infarction [ Time Frame: 1 year ]
    Number of patients experiencing myocardial infarction

  3. Urgent revascularization [ Time Frame: 1 year ]
    Number of patients experiencing urgent revascularization

  4. All cause mortality or myocardial infarction [ Time Frame: 1 year ]
    Number of patients experiencing all cause mortality or myocardial infarction

  5. Cardiovascular mortality [ Time Frame: 1 year ]
    Number of patients experiencing cardiovascular mortality

  6. Cardiovascular mortality, myocardial infarction, or urgent PCI [ Time Frame: 1 year ]
    Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI

  7. Cardiovascular mortality or myocardial infarction [ Time Frame: 1 year ]
    Number of patients experiencing cardiovascular mortality or myocardial infarction

  8. Admission for new onset of heart failure [ Time Frame: 1 year ]
    Number of patients experiencing admission for new onset of heart failure

  9. Peri-procedural (PCI) myocardial infarction [ Time Frame: 1 year ]
    Number of patients experiencing peri-procedural (PCI) myocardial infarction

  10. Peri-procedural (TAVI) myocardial infarction [ Time Frame: 1 year ]
    Number of patients experiencing peri-procedural (TAVI) myocardial infarction

  11. Any revascularization [ Time Frame: 1 year ]
    Number of patients experiencing any revascularization

  12. All-cause mortality, myocardial infarction, or urgent revascularization [ Time Frame: 30 days ]
    Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI

  13. Stroke or transient ischemic attack (TIA) [ Time Frame: 1 year ]
    Number of patients experiencing stroke or transient ischemic attack (TIA)

  14. Angina status (Seattle questionnaire), CCS and NYHA class [ Time Frame: 1 year ]
    Number of patients experiencing CCS and NYHA class

  15. Bleeding [ Time Frame: 1 year ]
    Number of patients experiencing bleeding

  16. Quality of life [ Time Frame: 1 year ]
    Number of patients experiencing Quality of life

  17. Acute kidney injury [ Time Frame: 1 year ]
    Number of patients experiencing acute kidney injury

  18. Target vessel revascularization [ Time Frame: 1 year ]
    Number of patients experiencing target vessel revascularization

  19. Target lession revascularization [ Time Frame: 1 year ]
    Number of patients experiencing target lession revascularization

  20. Cost effectiveness analysis [ Time Frame: 1 year ]
    Cost effectiveness analysis

  21. Stent thrombosis [ Time Frame: 1 year ]
    Number of patients experiencing stent thrombosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

And one of the following:

  1. Symptomatic (dyspnea corresponding to New York Heart Association (NYHA) class II or higher, angina pectoris, or cardiac syncope) or
  2. Asymptomatic but have a decline in left ventricular ejection fraction (LVEF), new onset of atrial fibrillation, or LV septal hypertrophy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058627


Contacts
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Contact: Jacob Lønborg, MD, PhD +4535458176 jacob.thomsen.loenborg@regionh.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Leif Thuesen         
Department of Cardiology, Skejby University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Christian J Terkelsen         
Rigshospitalet, Copenhagen University Hospital Recruiting
Copenhagen, Denmark
Contact: Jacob Loenborg, MD, PhD       jacob.thomsen.loenborg.01@regionh.dk   
Department of Cardiology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Karsten Veien         
Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Pasi Karjalainen         
Oulu University Hospital Recruiting
Oulu, Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Olli Kajander         
Turku University Hospital Not yet recruiting
Turku, Finland
Contact: Mikko Savontaus         
Latvia
Riga University Hospital Not yet recruiting
Riga, Latvia
Contact: Andrejs Erglis         
Sweden
Sahlgrenska Recruiting
Gothenburg, Sweden
Contact: Dan Ioanes         
Lund University Hospital Recruiting
Lund, Sweden
Contact: Sasha Koul         
Karolinska Recruiting
Stockholm, Sweden
Contact: Rickard Linder         
Sponsors and Collaborators
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Lund University Hospital
Karolinska University Hospital
Rikshospitalet University Hospital
Haukeland University Hospital
Helsinki University Central Hospital
Tampere University Hospital
Oulu University Hospital
Turku University Hospital
Kuopio University Hospital
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Thomas Engstrøm, MD, PhD Rigshospitalet University Hospital, Denmark
Principal Investigator: Lars Søndergaard, Professor Rigshospitalet University Hospital, Denmark
Principal Investigator: Jacob Lønborg, MD, PhD Rigshospitalet University Hospital, Denmark
Study Director: Matthias Götberg, MD, PhD Lund University Hospital, Sweden
Study Director: Christian J Terkelsen, MD, PhD Aarhus University Hospital, Denmark
Study Director: Leif Thuesen, MD, DMSci Aalborg University Hospital, Denmark
Study Director: Karsten Veien, MD Odense University Hospital
Study Director: Rickard Linder, MD, PhD Karolinska University Hospital
Study Director: Olli Kajander, MD, PhD Tampere University Hospital, Finland
Study Director: Pasi Karjalainen, MD, PhD Helsinki University Central Hospital, Finland
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Responsible Party: Thomas Engstrom, Consultant, PhD, DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03058627    
Other Study ID Numbers: H-16039929
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction