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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

Status: Recruiting

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

I'm interested

Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of severe symptomatic aortic valve stenosis and coronary artery disease
• successful transfemoral transcatheter aortic valve replacement (TAVR) defined as the implantation of a single transcatheter aortic valve within the past 96 hours
Exclusion Criteria:

• percutaneous coronary intervention (PCI) already completed less than 90 days before TAVR
• planned PCI or cardiac surgery
• additional significant heart or medical diagnosis (study team will review)
Conditions:

Heart & Vascular

Keywords:

Clinics and Surgery Center (CSC), Aortic Stenosis, Coronary Artery Disease, TAVR, transfemoral transcatheter aortic valve replacement

Contact(s): Julie Longman - longm021@umn.edu
Principal Investigator: Greg Helmer
Phase: NA
IRB Number: STUDY00012707
System ID: 32001
See this study on ClinicalTrials.gov

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