POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
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A vizsgálat adatai
- Ki végzi
- Erasmus Medical Center
- Azonosító
- NCT03910751
- A regiszteradat frissítve
- 2025. július 23.
- Eredeti leírás
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.A teljes eredeti leírásKevesebb
Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.
Bevonási feltételek: Eligible for ACURATE Neo valve implantation; Patient agrees to follow-up duration; Patient is able to understand and sign written informed consent.
Kizáró feltételek: Pregnancy; Cardiac; Pulmonary hypertension (sPAP > 60mmHg); No complex coronary artery disease; Presence of severe peripheral artery disease; Moderate to severely impaired left ventricular ejection fraction (LVEF <35%); GFR < 35ml/min; Frailty; BMI > 35; Mitral regurgitation > moderate; Untreated high degree AV-block or RBBB; Pulmonary; COPD Gold > 2; Kidney function; Inappropriate social support and/or (familial) care; Patient is walking aid dependent; TAVI strategy; Transfemoral approach not possible; Follow up; Inability to adhere to follow-up.