NOTION-3: Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

• Sponsor: Thomas Engstrom (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03058627
• Collaborator: Rigshospitalet, Denmark (Other), Aarhus University Hospital (Other), Aalborg University Hospital (Other), Odense University Hospital (Other), Lund University Hospital (Other), Karolinska University Hospital (Other), Haukeland University Hospital (Other), Helsinki University Central Hospital (Other), Tampere University Hospital (Other), Oulu University Hospital (Other), Turku University Hospital (Other), Sahlgrenska University Hospital, Sweden (Other), Pauls Stradins Clinical University Hospital (Other)
• Enrollment: 452
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 120.5
• Patients Per Site: 37.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Aortic Valve Stenosis; TAVI; PCI	Procedure: PCI	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 15, 2017
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

1. All cause mortality [Until the last included patients have been followed for 1 year after the TAVI]

   Number of patients experiencing all cause mortality

2. Myocardial infarction [Until the last included patients have been followed for 1 year after the TAVI]

   Number of patients experiencing myocardial infarction

3. Urgent revascularization [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 [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 [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 [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 [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 [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 [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 [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 [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) [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 [30 days and 1 year]

    Number of patients experiencing CCS and NYHA class

14. Bleeding [Until the last included patients have been followed for 1 year after the TAVI]

    Number of patients experiencing bleeding

15. Quality of Life [30 days and 1 year]

    Number of patients experiencing improvement in Quality of life

16. Acute kidney injury [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 [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 [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 [Until the last included patients have been followed for 1 year after the TAVI]

    Cost effectiveness analysis

20. Stent thrombosis [Until the last included patients have been followed for 1 year after the TAVI]

    Number of patients experiencing stent thrombosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University Hospital	Aalborg		Denmark
2	Department of Cardiology, Skejby University Hospital	Aarhus		Denmark	8200
3	Rigshospitalet, Copenhagen University Hospital	Copenhagen		Denmark
4	Department of Cardiology, Odense University Hospital	Odense		Denmark	5000
5	Helsinki University Hospital	Helsinki		Finland
6	Oulu University Hospital	Oulu		Finland
7	Tampere University Hospital	Tampere		Finland
8	Turku University Hospital	Turku		Finland
9	Riga University Hospital	Riga		Latvia
10	Sahlgrenska	Gothenburg		Sweden
11	Lund University Hospital	Lund		Sweden
12	Karolinska	Stockholm		Sweden

Sponsors and Collaborators

• Thomas Engstrom
• 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

Investigators

• Study Chair: Thomas Engstrøm, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark
• Principal Investigator: Jacob Lønborg, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark
• Study Chair: Lars Søndergaard, MD, DMSc, PhD, Rigshospitalet University Hospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Engstrom, Consultant, PhD, DMSci, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03058627
• Other Study ID Numbers: H-16039929
• First Posted: Feb 23, 2017
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis

Study Results

No Results Posted as of Feb 10, 2022