PerQseal® Elite Venous Clinical Study (ELITE-Venous)
Netherlands90 participantsStarted 2024-04-01
Plain-language summary
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Age ≥ 19 years.
✓. Clinically indicated for a percutaneous venous interventional catheter-based procedure, e.g., mitral valve edge to edge repair, left atrial appendage device closure, leadless pacemaker implantation, patent foramen ovale closure or use of a circulatory assist device or extracorporeal oxygenation using a common femoral venotomy created by a 14 to 22F sheath (venotomy up to 26F).
✓. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
✓. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
Exclusion criteria
✕. Evidence of current systemic bacterial or cutaneous infection, including groin infection,
✕. Known bleeding diathesis, unstable INR, definite or potential coagulopathy, platelet count \< 100,000/μl or subjects on long term anticoagulants with an INR \> 2.2 within 12 hours prior to index procedure,
✕. Significant anaemia (example: haemoglobin \< 8 g/dL or haematocrit \< 22%), within 24 hours prior to index procedure,
✕. Known type II heparin-induced thrombocytopenia,
✕. Documented right ventricular dysfunction \< 13%,
✕. Ipsilateral or contralateral lower extremity amputation,
✕
What they're measuring
1
Primary Safety Endpoint- Combined rate of both Major and Minor access site complications
Timeframe: through 30 Days
2
Primary Effectiveness Endpoint - Time to Haemostasis