NCT07413965 TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
| NCT ID | NCT07413965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Bicuspid Aortic Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2026-07-23 |
| Primary Completion | 2032-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2026-07-23 with a primary completion date of 2032-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Raj Makkar, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT07413965 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Bicuspid Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413965 currently recruiting?
Yes, NCT07413965 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cedars-Sinai Medical Center to inquire about joining.
Where is the NCT07413965 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07413965 clinical trial?
NCT07413965 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Raj Makkar, MD at Cedars-Sinai Medical Center. The trial plans to enroll 1,200 participants.