NCT04810195

Brief Summary

The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
3 countries

4 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

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

March 7, 2021

Last Update Submit

October 3, 2022

Conditions

Aortic Valve Stenosis

Keywords

TAVR

Outcome Measures

Primary Outcomes (1)

  • MACE

    any of * Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported) * Postoperative new permanent pacemaker (in hospital) * 30 days mortality * 30 days stroke * Acute Kidney Injury (AKIN grade 3) (in hospital)

    30 days

Secondary Outcomes (5)

  • Rate of Postoperative aortic insufficiency more than mild by transthoracic echo

    Within 7 days of procedure

  • Rate of Postoperative aortic insufficiency more than mild by aortography

    Same day as procedure

  • Postoperative aortic valve gradients

    Within 7 days of procedure

  • Rate of major acute procedural complications

    Same day as procedure

  • Procedural contrast use

    Same day as procedure

Interventions

Boston Scientific Acurate neo2 TAVR deviceDEVICE

The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The first 500 consecutive patients treated with the Acurate neo2 from up to 15 European sites which have started using the Acurate neo2.

You may qualify if:

  • that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rigshospitalet

Copenhagen, Denmark

Location

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Lund University Hospital

Lund, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Andreas Rück, MD PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 22, 2021

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

March 15, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Locations

DE(1)DK(1)SE(2)