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

Aortic Valve Stenosis Clinical Trial

— POLESTAR  

Official title:

Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03910751
• Other study ID #: POLESTAR_EMC2019
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: February 1, 2024
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	AZ Sint-Jan Brugge	Brugge
Belgium	UZ Brussel	Brussel
Belgium	AZ Maria Middelares	Gent
Canada	Royal Columbian Hospital	New Westminster
Canada	Sunnybrook Health Sciences Centre	Toronto
Canada	Vancouver General Hospital	Vancouver
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus University Medical Center	Rotterdam
Netherlands	Utrecht University Medical Center	Utrecht
United Kingdom	University Hospital Sussex NHS Foundation Trust	Brighton
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Canada,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint	Composite of all-cause mortality, any stoke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular, major access related, major cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation and valve-related dysfunction requiring repeat procedure at 30 days	30 days
Primary	Primary efficacy endpoint at 30 days	Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 30 days	30 days
Primary	Primary efficacy endpoint at 1 year	Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 1 year	1 year
Secondary	All-cause mortality	As defined by the most recent VARC document	30 days and 1 year
Secondary	Stroke	As defined by the most recent VARC document	30 days and 1 year
Secondary	Life threatening bleeding	As defined by the most recent VARC document	30 days and 1 year
Secondary	Acute kidney injury	As defined by the most recent VARC document	30 days and 1 year
Secondary	Coronary artery obstruction requiring intervention	As defined by the most recent VARC document	30 days and 1 year
Secondary	Major vascular complication	As defined by the most recent VARC document	30 days and 1 year
Secondary	Valve related dysfunction requiring repeat procedure	As defined by the most recent VARC document	30 days and 1 year
Secondary	All-cause rehospitalization	As defined by the most recent VARC document	30 days and 1 year
Secondary	Rehospitalization for valve-related symptoms or worsening congestive heart failure	As defined by the most recent VARC document	30 days and 1 year
Secondary	New permanent pacemaker implantation	As defined by the most recent VARC document	30 days and 1 year
Secondary	Myocardial infarction	As defined by the most recent VARC document	30 days and 1 year
Secondary	NYHA heart failure class III or IV	As defined by the most recent VARC document	30 days and 1 year
Secondary	Patient reported Quality of Life	As measured by the EQ5D-5L quality of life questionnaire	30 days and 1 year
Secondary	Patient reported Quality of Life	As measured by the KCCQ quality of life questionnaire	30 days and 1 year
Secondary	Categorical cost analysis	Derived from length of stay on Intensive care unit and general ward	30 days