TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

Summary

The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure. Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms. The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.

Eligibility

Inclusion Criteria:

1. 50 years of age or older at time of consent
2. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
3. Gated contrast CT available and suitable for core laboratory analysis;
4. BAV anatomy confirmed by CT core laboratory analysis

Exclusion Criteria:

1. Recent cardiovascular intervention within 30 days prior to randomization.
2. Presence of an existing TAVR or SAVR device
3. Pregnancy or lactation
4. Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
5. Active enrollment in another investigational study
6. Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee
7. Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45mm but site plan for surgery of the aorta in the event of randomization to surgery
8. Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
9. In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG)
10. Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR
11. Leukopenia (WBC \< 3000 cells/µL), anemia (Hgb \< 8 g/dL), Thrombocytopenia (Plt \< 50,000 cells/µL) on latest available labs within 30 days prior to randomization
12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization
13. LVEF \< 25% within 90 days prior to randomization
14. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization
15. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula)
16. Severe lung disease (FEV1 \< 50% predicted), unresolved prior to randomization
17. History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C
18. Unable to complete the KCCQ due cognitive impairment or other medical condition

Conditions2

Locations1 site

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