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

Primary Purpose

Coronary Artery Disease, Aortic Valve Stenosis, TAVI

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PCI
Sponsored by
Thomas Engstrom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)

Sites / Locations

  • Aalborg University Hospital
  • Department of Cardiology, Skejby University Hospital
  • Rigshospitalet, Copenhagen University Hospital
  • Department of Cardiology, Odense University Hospital
  • Helsinki University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Riga University Hospital
  • Sahlgrenska
  • Lund University Hospital
  • Karolinska

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TAVI only

TAVI + FFR-guided complete revascularization

Arm Description

TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All cause mortality
Number of patients experiencing all cause mortality
Myocardial infarction
Number of patients experiencing myocardial infarction
Urgent revascularization
Number of patients experiencing urgent revascularization
All cause mortality or myocardial infarction
Number of patients experiencing all cause mortality or myocardial infarction
Cardiovascular mortality
Number of patients experiencing cardiovascular mortality
Cardiovascular mortality, myocardial infarction, or urgent PCI
Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI
Cardiovascular mortality or myocardial infarction
Number of patients experiencing cardiovascular mortality or myocardial infarction
Admission for new onset of heart failure
Number of patients experiencing admission for new onset of heart failure
Peri-procedural (PCI) myocardial infarction
Number of patients experiencing peri-procedural (PCI) myocardial infarction
Peri-procedural (TAVI) myocardial infarction
Number of patients experiencing peri-procedural (TAVI) myocardial infarction
Any revascularization
Number of patients experiencing any revascularization
Stroke or transient ischemic attack (TIA)
Number of patients experiencing stroke or transient ischemic attack (TIA)
Angina status (Seattle questionnaire), CCS and NYHA class
Number of patients experiencing CCS and NYHA class
Bleeding
Number of patients experiencing bleeding
Quality of Life
Number of patients experiencing improvement in Quality of life
Acute kidney injury
Number of patients experiencing acute kidney injury
Target vessel revascularization
Number of patients experiencing target vessel revascularization
Target lession revascularization
Number of patients experiencing target lession revascularization
Cost effectiveness analysis
Cost effectiveness analysis
Stent thrombosis
Number of patients experiencing stent thrombosis

Full Information

First Posted
February 11, 2017
Last Updated
November 8, 2022
Sponsor
Thomas Engstrom
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Lund University Hospital, Karolinska University Hospital, Haukeland University Hospital, Helsinki University Central Hospital, Tampere University Hospital, Oulu University Hospital, Turku University Hospital, Sahlgrenska University Hospital, Sweden, Pauls Stradins Clinical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03058627
Brief Title
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
Acronym
NOTION-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Engstrom
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Lund University Hospital, Karolinska University Hospital, Haukeland University Hospital, Helsinki University Central Hospital, Tampere University Hospital, Oulu University Hospital, Turku University Hospital, Sahlgrenska University Hospital, Sweden, Pauls Stradins Clinical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Stenosis, TAVI, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAVI only
Arm Type
No Intervention
Arm Description
TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
Arm Title
TAVI + FFR-guided complete revascularization
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
FFR guided PCI
Primary Outcome Measure Information:
Title
All-cause mortality, myocardial infarction, or urgent revascularization
Description
Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Secondary Outcome Measure Information:
Title
All cause mortality
Description
Number of patients experiencing all cause mortality
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Myocardial infarction
Description
Number of patients experiencing myocardial infarction
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Urgent revascularization
Description
Number of patients experiencing urgent revascularization
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
All cause mortality or myocardial infarction
Description
Number of patients experiencing all cause mortality or myocardial infarction
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Cardiovascular mortality
Description
Number of patients experiencing cardiovascular mortality
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Cardiovascular mortality, myocardial infarction, or urgent PCI
Description
Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Cardiovascular mortality or myocardial infarction
Description
Number of patients experiencing cardiovascular mortality or myocardial infarction
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Admission for new onset of heart failure
Description
Number of patients experiencing admission for new onset of heart failure
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Peri-procedural (PCI) myocardial infarction
Description
Number of patients experiencing peri-procedural (PCI) myocardial infarction
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Peri-procedural (TAVI) myocardial infarction
Description
Number of patients experiencing peri-procedural (TAVI) myocardial infarction
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Any revascularization
Description
Number of patients experiencing any revascularization
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Stroke or transient ischemic attack (TIA)
Description
Number of patients experiencing stroke or transient ischemic attack (TIA)
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Angina status (Seattle questionnaire), CCS and NYHA class
Description
Number of patients experiencing CCS and NYHA class
Time Frame
30 days and 1 year
Title
Bleeding
Description
Number of patients experiencing bleeding
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Quality of Life
Description
Number of patients experiencing improvement in Quality of life
Time Frame
30 days and 1 year
Title
Acute kidney injury
Description
Number of patients experiencing acute kidney injury
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Target vessel revascularization
Description
Number of patients experiencing target vessel revascularization
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Target lession revascularization
Description
Number of patients experiencing target lession revascularization
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Cost effectiveness analysis
Description
Cost effectiveness analysis
Time Frame
Until the last included patients have been followed for 1 year after the TAVI
Title
Stent thrombosis
Description
Number of patients experiencing stent thrombosis
Time Frame
Until the last included patients have been followed for 1 year after the TAVI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrøm, MD, DMSC, PhD
Organizational Affiliation
Rigshospitalet University Hospital, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacob Lønborg, MD, DMSC, PhD
Organizational Affiliation
Rigshospitalet University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Søndergaard, MD, DMSc, PhD
Organizational Affiliation
Rigshospitalet University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Department of Cardiology, Skejby University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet, Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
Riga University Hospital
City
Riga
Country
Latvia
Facility Name
Sahlgrenska
City
Gothenburg
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Karolinska
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

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