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A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with
Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone
in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter

Aortic Valve Replacement: The COMPLETE TAVR Study

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The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.

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This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia] AND
• Coronary artery disease defined as: (at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment that is at least 2.5 mm in diameter that is not a CTO and is amenable to treatment with percutaneous coronary intervention (PCI)) AND
• Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve replacement. AND
• Successful TAVR defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications
Exclusion Criteria:

• PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
• Planned PCI of coronary artery lesion(s)
• Planned surgical revascularization of coronary artery lesion(s)
• Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
• Any factor precluding 5-year follow-up
• Prior coronary artery bypass grafting surgery or surgical valve replacement
• Severe mitral regurgitation (> 3+)
• Severe left ventricular dysfunction (LVEF < 30%)
• Low coronary takeoff (high risk for coronary obstruction)
• Acute myocardial infarction within 90 days
• Stroke or transient ischemic attack within 90 days
• Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx
• Hemodynamic or respiratory instability

Procedure: Percutaneous Coronary Intervention (PCI)

Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis

Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Coronary Artery Disease, Aortic Stenosis, Clinics and Surgery Center (CSC)

Julie Longman - longm021@umn.edu
Greg Helmer
N/A
STUDY00012707
NCT04634240
See this study on ClinicalTrials.gov

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