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 - 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

Shonan Kamakura General Hospital0 sites100 target enrollmentSeptember 9, 2023

Conditionssevere aortic stenosis

Overview

Phase: 未知
Intervention: Not specified
Conditions: severe aortic stenosis
Sponsor: Shonan Kamakura General Hospital
Enrollment: 100
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 9, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Shonan Kamakura General Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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