Active, not recruitingNo phase
ACURATE neo2™ Post Market Clinical Follow up Study
Key facts
- Who runs it
- Boston Scientific Corporation
- Where
- Denmark, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and United Kingdom19 sites in 8 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 250 people enrolled
- Started
- 16 Dec 2020
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- Transcatheter Aortic Valve Implantation/Replacement
- Record updated
- 25 June 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU
Who cannot take part
- EC1. Subject has a previous bioprosthesis in the aortic position
- EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure
- Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation
- EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)
- EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.
Treatments tested
- Transcatheter Aortic Valve Implantation/Replacement
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 25 June 2025