Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Boston Scientific Acurate neo2 TAVR device

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).

• Study Type: Observational
• Enrollment (Actual): 554

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff Klinik
• Sweden
  • Lund, Sweden
    • Lund University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Postoperative aortic insufficiency more than mild by transthoracic echo	Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency	Within 7 days of procedure
Rate of Postoperative aortic insufficiency more than mild by aortography	Core-lab analysis of the aortogram in the end of the procedure for quantification of aortic insufficiency (videodensitometry): rate of patients with more than mild insuffiency	Same day as procedure
Postoperative aortic valve gradients	Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram	Within 7 days of procedure
Rate of major acute procedural complications	Intraprocedural complications such as valve embolization, need for second valve, anular rupture	Same day as procedure
Procedural contrast use	The average amount of contrast in ml per procedure	Same day as procedure

Collaborators and Investigators

• Sponsor: Andreas Rück
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Andreas Rück, MD PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: TAVR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HKN AR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No