Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

NCT ID: NCT04810195

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 554 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-03-15

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.

Detailed Description

Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.

Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.

Karolinska will be the coordinating center for data collection.

Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).

Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).

Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Boston Scientific Acurate neo2 TAVR device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Andreas Rück

OTHER

Sponsor Role: lead

Responsible Party

Andreas Rück

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreas Rück, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Rigshospitalet

Copenhagen, , Denmark

Kerckhoff Klinik

Bad Nauheim, , Germany

Lund University Hospital

Lund, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Denmark; Germany; Sweden

Other Identifiers

HKN AR01

Identifier Type: -

Identifier Source: org_study_id