Observation study of a new developed occluder for closure of the persistent foramen ovale (PFO)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007172

Enrollment

334

Registered

2015-07-13

Start date

2015-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cryptogenic stroke Q21.1

Interventions

Group 1: Patient data collected at the minimal invasive implantation of the acoredis PFO occluder and during follow-up until 5 years will be analysed. The closure of the defect in the atrail septum wi

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: indication: PFO closure

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
closure of PFO 6 months after implantation with testing form CRF 2: tick size of shunt [(a) no/ minimal shunt; (b) moderate shunt; (c) big shunt)]	—

Secondary

Measure	Time frame
complications at the day of the implantation and until 5 years after implantation with testing form CRF 1 and 2: tick occurred complications	—

Countries

Germany

Contacts

Public ContactHorst Sievert

CVC Frankfurt/ Main

info@cvcfrankfurt.de069 46031344

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026