Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 19

Inclusion Criteria

1. Age >= 19 years.
2. 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 24F sheath (venotomy up to 26F).
3. Subject is willing and able to provide appropriate study-specific informed
consent, follow protocol procedures, and comply with follow-up visit
requirements.
4. Females who are not pregnant or lactating and not planning to become
pregnant for the duration of the study.

Exclusion Criteria

Baseline Exclusion Criteria: If any Baseline or Procedural Exclusion Criteria
listed below are met, then closure with PerQseal Elite device is not permitted,
1. Evidence of current systemic bacterial or cutaneous infection, including
groin infection,
2. 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 or uninterrupted NOAC
administration,
3. Significant anaemia (example: haemoglobin < 8 g/dL or haematocrit < 22%),
within 24 hours prior to index procedure,
4. Known type II heparin-induced thrombocytopenia,
5. Documented right ventricular dysfunction < 13%,
6. Ipsilateral or contralateral lower extremity amputation,
7. Previous groin surgery within the region of the ipsilateral vessel access,
8. Common femoral vein diameter stenosis > 50% or previous bypass surgery/stent
placement in the common femoral vein of target leg,
9. Known existing nerve damage in the target leg,
10. Nephrotic syndrome or renal insufficiency (baseline serum creatinine > 2.5
mg/dl) or albumin level < 3.5 g/dl or symptoms of pitting oedema,
11. Systolic pulmonary artery pressure > 60 mmHg
12. Known allergy to any of the materials used in the PerQseal Elite device
(refer to Investigator*s Brochure),
13. Subject is unsuitable for surgical repair of the target leg access site,
14. Subject has undergone a percutaneous procedure greater than 8F sheath in
the target vessel, within the 90-days prior to index procedure,
15. Subject has undergone a percutaneous procedure of 8F sheath or less using
an absorbable intravascular closure device for haemostasis, in the target
vessel, within the 90-days prior to index procedure,
16. Subject has undergone a percutaneous procedure of 8F sheath or less using a
suture mediated closure device or manual/mechanical pressure for haemostasis in
the target vessel, within the 30-days prior to index procedure,
17. History of DVT or pulmonary embolism or venous thrombotic event,
18. Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg,
19. Further planned endovascular/catheter-based procedure in the target leg in
the 30- days following the index procedure,
20. Subject is enrolled in another investigational medical device or drug study,
21. Subject has been previously enrolled in this clinical study,
22. Subject is unable to maintain ipsilateral leg still during the index
procedure (restless leg syndrome),
23. Current COVID-19 infection (with or without symptoms), recent positive test
for COVID- 19 within two weeks, or recent exposure to a person with COVID-19
infection within two weeks.

Procedural Exclusion Criteria: *
24. Anatomically the common femoral vein is substantially posterior to the
femoral artery,
confirmed by Duplex ultrasound,
25. Initial common femoral venous access achieved other than with the use of an
ultrasound guided access approach,
26. If the venous access is, or suspected of being, via an artery,
27. Difficult dilation during initial target femoral vein access (e.g., that
damages or kinks dilators) while step-dilating up to the large-bore device,
28. During venous puncture, the target femoral vein suspected to have
experienced a posterior venous wall needle puncture or