NCT03910751

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

July 23, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

March 26, 2019

Last Update Submit

July 18, 2025

Conditions

Aortic Valve Stenosis

Keywords

TAVITAVREarly dischargeACURATE Neo

Outcome Measures

Primary Outcomes (3)

  • 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 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 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 Outcomes (15)

  • All-cause mortality

    30 days and 1 year

  • Stroke

    30 days and 1 year

  • Life threatening bleeding

    30 days and 1 year

  • Acute kidney injury

    30 days and 1 year

  • Coronary artery obstruction requiring intervention

    30 days and 1 year

  • +10 more secondary outcomes

Interventions

Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic BioprosthesisDEVICE

Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Eligible for ACURATE Neo valve implantation
  • Patient agrees to follow-up duration
  • Patient is able to understand and sign written informed consent

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

ASZ Aalst

Aalst, Belgium

Location

AZ Sint-Jan Brugge

Bruges, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

Royal Columbian Hospital

New Westminster, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Canada

Location

Vancouver General Hospital

Vancouver, Canada

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Utrecht University Medical Center

Utrecht, Netherlands

Location

University Hospital Sussex NHS Foundation Trust

Brighton, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Nicolas Van Mieghem, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 10, 2019

Study Start

April 1, 2019

Primary Completion

December 5, 2022

Study Completion

January 24, 2024

Last Updated

July 23, 2025

Record last verified: 2025-06

Locations

CA(3)GB(3)BE(4)NL(5)