ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy

J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy

The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.

Inclusion Criteria:

• 1) Age ≥65 years；

• 2) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters

  1. LVEF ≤55%
  2. LVESD >50 mm
  3. LVESDi >22 mm/m2
  4. LVESVi >45 mL/m2
  5. normal LV systolic function at rest (LVEF >55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension [LVEDD] >65 mm),

• 3) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement

• 4) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits

Exclusion Criteria:

• 1. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation

• 2. Moderate or severe aortic valve stenosis

• 3. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention

• 4. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion)

• 5. Subject is high-risk for SAVR as determined by the local heart team

• 6. Subject refuses SAVR as a treatment option

• 7. Subject is selected for aortic valve repair or aortic surgery

• 8. Need for emergency surgery or TAVR for any reason

• 9. Anatomical exclusion criteria (ANY of the following):

  1. Aortic Annulus Perimeter <53 mm or >94 mm measured by CT
  2. Maximal ascending aortic diameter ≥50 mm
  3. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy
  4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).
  5. Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.

• 10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit

• 11. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit

• 12. Any condition considered a contraindication to mechanical circulatory support

• 13. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.)

• 14. Subject refuses blood transfusion

• 15. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention

• 16. Evidence of acute myocardial infarction within 30 days of the screening visit

• 17. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)

• 18. Complex coronary artery disease (one of the following):

  1. Unprotected left main coronary artery disease ≥50%
  2. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is >2.5 mm
  3. Chronic total occlusion (CTO)
  4. Long lesion, expected stent length >38 mm
  5. Multivessel lesion (at least 2 coronary arteries require interventional treatment)
  6. Need to use multiple stents (planned > 3 stents)
  7. Lesion with in-stent restenosis
  8. Severe calcification lesion
  9. Coronary ostial lesion
  10. Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR.

• 19. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit

• 20. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit

• 21. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction <25%; or left ventricular end-systolic diameter (LVESD) >70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation.

• 22. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory

• 23. Cardiac imaging (echocardiography, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation

• 24. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure

• 25. Uncontrolled atrial fibrillation (i.e., resting heart rate >120 bpm)

• 26. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022/ ACC 2020

• 27. Untread Leukopenia (WBC<3.0*109/L), Untread Thrombocytopenia (Platelet count <50*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin <9.0 g/dL)

• 28. Severe chronic obstructive pulmonary disease (COPD) (FEV1 <50% predicted) or currently on home oxygen

• 29. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2/3 systemic pressure)

• 30. Severe chronic liver disease (Child-Pugh C) or any active liver disease

• 31. Renal insufficiency (eGFR<30mL/min/1.73m²) and/or requiring chronic peritoneal dialysis at the time of screening and/or requiring chronic hemodialysis at the time of screening

• 32. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks

• 33. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated

• 34. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure

• 35. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy

• 36. BMI >50 kg/m2 or <18.5 kg/m2

• 37. Estimated life expectancy <24 months due to associated non- cardiac comorbid conditions

• 38. Immobility that would prevent completion of study procedures

• 39. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary

• 40. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)

• 41. Pregnancy or intent to become pregnant (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study)

• 42. Other patients considered unsuitable for this clinical study by the investigator