Active — Not RecruitingNot Applicable

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

Switzerland200 participantsStarted 2021-03-31

Plain-language summary

The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. History of embolic events such as cryptogenic stroke or systemic embolism (single event or multiple events). A stroke is considered to be cryptogenic if no possible cause can be determined despite extensive workup according to the standard protocol of the participating center (TOAST classification 5b) (29). Before inclusion in the study, the following tests are required as standard tests to establish the diagnosis of cryptogenic stroke:

✕. Cardiac monitoring is planned to be performed with the BIOMONITOR III(m) device
✕. Presence of right-to-left shunt through a PFO as assessed by means of transesophageal echocardiography (TEE) with agitated saline while the patient is at rest or while a Valsalva maneuver is being performed.
✕. Occlusion of PFO is planned to be performed with the AMPLATZERTM PFO OCCLUDER device.
✕. Patient is willing to sign patient consent form.
✕. Age ≥18 years.
✕. Known etiology of the embolic event (based on neuro-/cardiac/vascular imaging), such as:
✕. Atrial septal defect or ventricular septal defect.
✕. Coronary or valvular disease requiring surgical intervention.

incidence of first AF within 12 months after percutaneous PFO occlusion

Timeframe: 12 months

NCT IDNCT04881578

SponsorRaban Jeger

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11-30