Clinical trial NCT04810195: Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Official title: Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: TAVR
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2021-03-22
Enrollment: 554
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: MACE
timeFrame: 30 days
Secondary outcomes:
measure: Rate of Postoperative aortic insufficiency more than mild by transthoracic echo
timeFrame: Within 7 days of procedure
measure: Rate of Postoperative aortic insufficiency more than mild by aortography
timeFrame: Same day as procedure
measure: Postoperative aortic valve gradients
timeFrame: Within 7 days of procedure
measure: Rate of major acute procedural complications
timeFrame: Same day as procedure
measure: Procedural contrast use
timeFrame: Same day as procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Andreas Rück, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: