Brief Title
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
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
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.
Study Type
Interventional
Primary Outcome
All-cause mortality, myocardial infarction, or urgent revascularization
Secondary Outcome
All cause mortality
Condition
Coronary Artery Disease
Intervention
PCI
Study Arms / Comparison Groups
TAVI only
Description: TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
452
Start Date
September 15, 2017
Completion Date
September 30, 2027
Primary Completion Date
March 31, 2022
Eligibility 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Engstrøm, MD, PhD, +4535458176, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03058627
Organization ID
H-16039929
Responsible Party
Principal Investigator
Study Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital
Study Sponsor
Thomas Engstrøm, MD, PhD, Principal Investigator, Rigshospitalet University Hospital, Denmark
Verification Date
February 2020