Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
NCT ID: NCT03058627
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
454 participants
INTERVENTIONAL
2017-09-15
2027-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVI only
TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
No interventions assigned to this group
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 .
PCI
FFR guided PCI
Interventions
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PCI
FFR guided PCI
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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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_GOV
Sahlgrenska University Hospital
OTHER
Pauls Stradins Clinical University Hospital
OTHER
Thomas Engstrom
OTHER
Responsible Party
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Thomas Engstrom
Consultant, PhD, DMSci
Principal Investigators
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Thomas Engstrøm, MD, DMSC, PhD
Role: STUDY_CHAIR
Rigshospitalet University Hospital, Denmark
Jacob Lønborg, MD, DMSC, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet University Hospital, Denmark
Lars Søndergaard, MD, DMSc, PhD
Role: STUDY_CHAIR
Rigshospitalet University Hospital, Denmark
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Department of Cardiology, Skejby University Hospital
Aarhus, , Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Department of Cardiology, Odense University Hospital
Odense, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Riga University Hospital
Riga, , Latvia
Sahlgrenska
Gothenburg, , Sweden
Lund University Hospital
Lund, , Sweden
Karolinska
Stockholm, , Sweden
Countries
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References
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Lonborg J, Jabbari R, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Ioanes D, Terkelsen CJ, Kajander OA, Koul S, Savontaus M, Karjalainen P, Erglis A, Minkkinen M, Sorensen R, Tilsted HH, Holmvang L, Bieliauskas G, Ellert J, Piuhola J, Eftekhari A, Angeras O, Ruck A, Christiansen EH, Jorgensen T, Ozbek BT, Glinge C, Sondergaard L, De Backer O, Engstrom T; NOTION-3 Study Group. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2024 Dec 12;391(23):2189-2200. doi: 10.1056/NEJMoa2401513. Epub 2024 Aug 31.
Other Identifiers
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H-16039929
Identifier Type: -
Identifier Source: org_study_id