Prospective, multicenter, randomized trial.
Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF \<30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGClinical worsening
A composite of all cause death, disabling stroke, or heart failure rehospitalization
Time frame: 12 months
Procedural complications
Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.
Time frame: 12 months
6-minute walk distance
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time frame: 12 months
New York Heart Association (NYHA) functional class
Classification of function capacity of the NYHA.
Time frame: 12 months
Stroke
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Time frame: 12 months
Mortality
All-cause, cardiovascular, and non-cardiovascular mortality
Time frame: 12 months
Bleeding Complications
The original VARC definitions with BARC classifications
Time frame: 12 months
Prothetic valve dysfunction
Any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
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Time frame: 12 months
Rehospitalization
Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure.
Time frame: 12 months