severe aortic stenosis
Conditions
Interventions
The aim of this study was to prospectively evaluate the efficacy and safety of newly proposed algorithm for determining the patient-specific valve implantation depth and delivery cagtheter rotation an
Sponsors
Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Severe aortic stenosis with New York Heart Association (NYHA) grade 2 or higher 2)Patients indicated for TAVI based on the guidelines for the treatment of valvular disease in Japan as a result of consultation in the Heart Team at each site 3)Subjects who were judged to be anatomically suitable for TAVI via the femoral approach with Evolut FX system by preoperative computed tomography at the consultation in the heart team of each site. 4)Subjects who gave written informed consent on their own free will after receiving sufficient explanation for participation in this study
Exclusion criteria
Exclusion criteria: 1)Study subjects with low quality of preoperative CT 2)Prior pacemaker or ICD implantation 3)Prior prosthetic valve implantation in the aortic position 4)Patients with bicuspid aortic valve 5)Contraindications for implantation of bioprosthetic valves 6)Patients with allergy, hypersensitivity or contraindication to any of the following Aspirin or heparin, Ticlopidine and clopidogrel, Nitinol (titanium or nickel), Contrast medium 7)Patients with preoperative renal impairment (eGFR <30 ml/min/1.73m2), or patients on chronic dialysis 8)Patients with left ventricular ejection fraction <30% as measured by preoperative transthoracic cardiac ultrasound. 9)Patients with NYHA IV decompensated heart failure 10)Patients receiving hemodynamic support with circulatory assist devices for cardiogenic shock 11)Persistent sepsis, including active endocarditis 12)Patients with left ventricular thrombus 13)Anatomically unsuitable for TAVI via the femoral approach 14)Patients for whom surgical valvular surgery is indicated by the Heart Team 15)Having any of the following hematologic disorders: leukopenia (white blood cell count < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3). 16)Patients who are pregnant or breastfeeding 17)Currently participating in other clinical trials (excluding registry studies) of investigational drugs or other devices 18)Severe dementia (leading to an inability to receive an explanation for consent for the procedure or difficulty in a follow-up visit after the procedure) 19)Life expectancy is less than 12 months due to non-cardiac comorbidities 20)Patients who have difficulty agreeing on their own will due to cognitive decline 21)Other patients considered by the Principal Investigator to be inappropriate as study subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Coronary access after TAVI or risk of sinus sequestration in TAVI-in-TAVI as assessed by post-TAVI CT 2)Rate of permanent pacemaker implantation at 30 days after TAVI or incidence of new left bundle branch block on ECG at discharge after TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Percentage of success in TAVI implantation at a position preoperatively pre-defined by PODCAST approach 2)Number of recaptures during implantation of the TAVI valve | — |
Countries
Japan
Contacts
Public ContactTomoki Ochiai
Shonan Kamakura General Hospital Department of Cardiology
Outcome results
None listed