POLESTAR Trial - An International Multi-center Early Discharge TAVI Program

Erasmus University

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03910751

POLESTAR_EMC2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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