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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI only | No Intervention | TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion. | |
| TAVI + FFR-guided complete revascularization | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | FFR guided PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality, myocardial infarction, or urgent revascularization | Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Number of patients experiencing all cause mortality | Until the last included patients have been followed for 1 year after the TAVI |
| Myocardial infarction | Number of patients experiencing myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Engstrøm, MD, DMSC, PhD | Rigshospitalet University Hospital, Denmark | Study Chair |
| Jacob Lønborg, MD, DMSC, PhD | Rigshospitalet University Hospital, Denmark | Principal Investigator |
| Lars Søndergaard, MD, DMSc, PhD | Rigshospitalet University Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Department of Cardiology, Skejby University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41371788 | Derived | Jorgensen TH, Engstrom T, Jabbari R, Glinge C, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Sorensen R, Holmvang L, Ioanes D, Terkelsen CJ, Ellert-Gregersen J, Christiansen EH, Eftekhari A, Piuhola J, Kajander O, Koul S, Savontaus M, Karjalainen P, Sondergaard L, De Backer O, Lonborg J. Fractional Flow Reserve to Guide Revascularization in Patients With Coronary Artery Disease Undergoing TAVR. JACC Cardiovasc Interv. 2025 Dec 8;18(23):2925-2936. doi: 10.1016/j.jcin.2025.10.015. | |
| 39216095 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
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| Until the last included patients have been followed for 1 year after the TAVI |
| Urgent revascularization | Number of patients experiencing urgent revascularization | Until the last included patients have been followed for 1 year after the TAVI |
| All cause mortality or myocardial infarction | Number of patients experiencing all cause mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI |
| Cardiovascular mortality | Number of patients experiencing cardiovascular mortality | Until the last included patients have been followed for 1 year after the TAVI |
| Cardiovascular mortality, myocardial infarction, or urgent PCI | Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI |
| Cardiovascular mortality or myocardial infarction | Number of patients experiencing cardiovascular mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI |
| Admission for new onset of heart failure | Number of patients experiencing admission for new onset of heart failure | Until the last included patients have been followed for 1 year after the TAVI |
| Peri-procedural (PCI) myocardial infarction | Number of patients experiencing peri-procedural (PCI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI |
| Peri-procedural (TAVI) myocardial infarction | Number of patients experiencing peri-procedural (TAVI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI |
| Any revascularization | Number of patients experiencing any revascularization | Until the last included patients have been followed for 1 year after the TAVI |
| Stroke or transient ischemic attack (TIA) | Number of patients experiencing stroke or transient ischemic attack (TIA) | Until the last included patients have been followed for 1 year after the TAVI |
| Angina status (Seattle questionnaire), CCS and NYHA class | Number of patients experiencing CCS and NYHA class | 30 days and 1 year |
| Bleeding | Number of patients experiencing bleeding | Until the last included patients have been followed for 1 year after the TAVI |
| Quality of Life | Number of patients experiencing improvement in Quality of life | 30 days and 1 year |
| Acute kidney injury | Number of patients experiencing acute kidney injury | Until the last included patients have been followed for 1 year after the TAVI |
| Target vessel revascularization | Number of patients experiencing target vessel revascularization | Until the last included patients have been followed for 1 year after the TAVI |
| Target lession revascularization | Number of patients experiencing target lession revascularization | Until the last included patients have been followed for 1 year after the TAVI |
| Cost effectiveness analysis | Cost effectiveness analysis | Until the last included patients have been followed for 1 year after the TAVI |
| Stent thrombosis | Number of patients experiencing stent thrombosis | Until the last included patients have been followed for 1 year after the TAVI |
| Aarhus |
| 8200 |
| Denmark |
| Rigshospitalet, Copenhagen University Hospital | Copenhagen | Denmark |
| Department of Cardiology, Odense University Hospital | Odense | 5000 | 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 |
| Derived |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |