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Completed

NCT Number: NCT04810195

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Boston Scientific Acurate neo2 TAVR device

Device

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

Primary outcomes

  1. MACE

    Time frame: 30 days

    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)

Secondary outcomes

  1. Rate of Postoperative aortic insufficiency more than mild by transthoracic echo

    Time frame: Within 7 days of procedure

    Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency

  2. Rate of Postoperative aortic insufficiency more than mild by aortography

    Time frame: Same day as procedure

    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

  3. Postoperative aortic valve gradients

    Time frame: Within 7 days of procedure

    Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram

  4. Rate of major acute procedural complications

    Time frame: Same day as procedure

    Intraprocedural complications such as valve embolization, need for second valve, anular rupture

  5. Procedural contrast use

    Time frame: Same day as procedure

    The average amount of contrast in ml per procedure

Sponsors and collaborators

Lead sponsor

Andreas Rück

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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