Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
- Conditions
- severe aortic stenosis
- Registration Number
- JPRN-UMIN000051896
- Lead Sponsor
- Shonan Kamakura General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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