Brief Title
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
Official Title
Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
Brief Summary
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.
Detailed Description
In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.
Study Type
Observational [Patient Registry]
Primary Outcome
Primary safety endpoint
Secondary Outcome
All-cause mortality
Condition
Aortic Valve Stenosis
Intervention
Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
250
Start Date
April 1, 2019
Completion Date
February 1, 2024
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria: - Eligible for ACURATE Neo valve implantation - Patient agrees to follow-up duration - Patient is able to understand and sign written informed consent Exclusion Criteria: - BMI > 35 - Pregnancy Cardiac - Moderate to severely impaired left ventricular ejection fraction (LVEF <35%) - Mitral regurgitation > moderate - Pulmonary hypertension (sPAP > 60mmHg) - No complex coronary artery disease - Untreated high degree AV-block or RBBB Pulmonary - COPD Gold > 2 Kidney function - GFR < 35ml/min Frailty - Inappropriate social support and/or (familial) care - Patient is walking aid dependent TAVI strategy - Presence of severe peripheral artery disease - Transfemoral approach not possible Follow up - Inability to adhere to follow-up
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas Van Mieghem, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03910751
Organization ID
POLESTAR_EMC2019
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Collaborators
Boston Scientific Corporation
Study Sponsor
Nicolas Van Mieghem, MD, PhD, Principal Investigator, Erasmus Medical Center
Verification Date
July 2022