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Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

RecruitingNAAges any - anyAllUniversity of British Columbia
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In plain words

What the trial is, and whether it could suit you

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAV

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: \- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia) AND \- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI AND \- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral 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 SAVR. Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have: \[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\] OR \[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\] OR patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate. AND \- Successful transfemoral 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
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What it tests

  • Percutaneous Coronary Intervention (PCI)
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Where

72 sites
Huntsville Heart Center
Huntsville, United States
Arizona Cardiovascular Research
Phoenix, United States
Veteran Affairs Palo Alto Health Care System
Palo Alto, United States
Loma Linda University
Redlands, United States
Santa Barbara Cottage Hospital
Santa Barbara, United States
Torrance Memorial Medical Center
Torrance, United States
JFK Medical Center
Atlantis, United States
Baptist Health Jacksonville
Jacksonville, United States

…and 64 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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