Clinical trial NCT03910751: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: TAVI
TAVR
Early discharge
ACURATE Neo
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2019-04-10
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 patients with severe AS and selected for TF-TAVI with the ACURATE Neo valve and eligible for early discharge within 48 hours post TAVI

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.

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

Primary outcomes:
measure: Primary safety endpoint
timeFrame: 30 days
measure: Primary efficacy endpoint at 30 days
timeFrame: 30 days
measure: Primary efficacy endpoint at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days and 1 year
measure: Stroke
timeFrame: 30 days and 1 year
measure: Life threatening bleeding
timeFrame: 30 days and 1 year
measure: Acute kidney injury
timeFrame: 30 days and 1 year
measure: Coronary artery obstruction requiring intervention
timeFrame: 30 days and 1 year
measure: Major vascular complication
timeFrame: 30 days and 1 year
measure: Valve related dysfunction requiring repeat procedure
timeFrame: 30 days and 1 year
measure: All-cause rehospitalization
timeFrame: 30 days and 1 year
measure: Rehospitalization for valve-related symptoms or worsening congestive heart failure
timeFrame: 30 days and 1 year
measure: New permanent pacemaker implantation
timeFrame: 30 days and 1 year
measure: Myocardial infarction
timeFrame: 30 days and 1 year
measure: NYHA heart failure class III or IV
timeFrame: 30 days and 1 year
measure: Patient reported Quality of Life
timeFrame: 30 days and 1 year
measure: Patient reported Quality of Life
timeFrame: 30 days and 1 year
measure: Categorical cost analysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Brussel
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Center
city: Brighton
country: United Kingdom
facility: University Hospital Sussex NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas Van Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: