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

Recruiting

• Conditions: cryptogenic stroke; Q21.1; Atrial septal defect

• Registration Number: DRKS00007172
• Lead Sponsor: Acoredis GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

indication: PFO closure

Exclusion Criteria

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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