NCT02882815

Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder

Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future. Patients will undergo routine examination, procedure and follow-up. Related data will be collected and kept in a way that patient info is well protected.

Detailed description

This is a Post Market Clinical Follow-up study. Informed consent will be obtained from the patient or from a legally authorized representative of the patient at screening. The patients will be screened (pre-procedure) to determine eligibility for the study. At screening, patients will be assessed for study eligibility by the inclusion/exclusion criteria through their medical history, demographics and transthoracic echocardiography (TTE). Participating patients will have their PFO closed using the IrisFITTM PFO Occluder device. The patients will undergo a clinical examination, electrocardiogram (ECG), clinical laboratory assessment and transthoracic echocardiography (TTE). All periprocedural procedures will be performed according to site´s standard of care.. The efficacy and safety of the devices will be assessed by ECGs, vital signs, physical examination and TTE, which will be done at 1day, at 1month and at 6 months post procedure. Safety will also be assessed at 12 months by telephone visit.

Conditions

• Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	IrisFIT PFO Occluder

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-11-01
• Completion: 2017-01-01
• First posted: 2016-08-30
• Last updated: 2018-08-09

Locations

3 sites across 2 countries: Germany, Ireland