Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

Aortic Valve Stenosis Clinical Trial

Official title:

Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810195
• Other study ID #: HKN AR01
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: October 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: March 15, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Boston Scientific Acurate neo2 TAVR device
The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Germany	Kerckhoff Klinik	Bad Nauheim
Sweden	Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Andreas Rück	Boston Scientific Corporation

Countries where clinical trial is conducted

Denmark,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative aortic valve gradients	Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram	Within 7 days of procedure
Secondary	Rate of major acute procedural complications	Intraprocedural complications such as valve embolization, need for second valve, anular rupture	Same day as procedure
Secondary	Procedural contrast use	The average amount of contrast in ml per procedure	Same day as procedure