TAVR vs SAVR for severe bicuspid aortic valve stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in adults with severe bicuspid aortic valve stenosis. Eligible participants undergo imaging-guided randomization 1:1 to receive either TAVR or SAVR, with follow-up at 30 days, one year, and annually up to 10 years. Patients qualifying for the randomized portion are analyzed to determine which procedure provides better outcomes, while those who do not qualify continue in registry arms for observational follow-up. The study uses contemporary, FDA-approved devices and aims to generate evidence to guide personalized treatment decisions for this anatomical subgroup. The trial builds on prior work but addresses the unique anatomy of bicuspid valves, where data have historically been limited.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Raj Makkar, MD — Cedars-Sinai Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing new bioprosthetic aortic valves for heart surgery

  This study is testing two new types of heart valves to see which one works better for younger patients needing aortic valve replacement surgery.

  Recruiting Instituto Dante Pazzanese de Cardiologia · São Paulo, São Paulo · NCT06688448

• Fisetin for Lung Health in Older Adults

  Researchers are testing whether a short course of the supplement fisetin can improve lung function and aging-related biomarkers in people 60 and older, including both smokers and never-smokers.

  Recruiting Phase 2 Cedars-Sinai Medical Center · Los Angeles, California · NCT07676435

• Transcatheter vs. Surgical Repair for Degenerative Mitral Valve Disease

  This study compares TEER, a catheter-based repair, with traditional surgical mitral repair in people aged 60 and older with degenerative mitral valve disease to see which approach works better in the long run.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT07605715

• Combining IV immunotherapy with liver-directed procedures to downstage hepatocellular carcinoma

  This tests whether giving IV immunotherapy (tremelimumab plus durvalumab) together with a liver-directed procedure (Y90, TACE, or RFA) can shrink or control hepatocellular carcinoma in adults with intermediate or advanced disease so more people may become eligible for liver transplant.

  Recruiting Phase 2 Cedars-Sinai Medical Center · Los Angeles, California · NCT07489976

• Bupivacaine with Epinephrine Sprayed Under the Diaphragm During Laparoscopy

  This study tests whether spraying bupivacaine with epinephrine under the diaphragm during laparoscopic gynecologic surgery reduces postoperative shoulder pain.

  Recruiting Phase 4 Cedars-Sinai Medical Center · Los Angeles, California · NCT07400146

• Virtual reality to prevent delirium in the ICU

  This project will try daily 15-minute virtual reality sessions to see if they reduce delirium in high-risk, non-intubated adult surgical ICU patients.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT07357389

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.