Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ MRI or computed tomography (CT) of the neurocranium (documenting ischemic embolic stroke)

⁃ 12-lead ECG (exclusion of AF)

⁃ Continuous ECG monitoring for at least 7 days (inpatient telemetry or Holter-ECG as an in- or outpatient

⁃ Ultrasonography, CT or MRI angiography of head and neck to rule out arterial disease as a cause of stroke (see below), or other potential causes of 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.

Locations
Other Locations
Switzerland
University Hospital Basel, Heart Center
Basel
University Hospital Bern Inselspital Cardiology
Bern
Cantonal Hospital St.Gallen Cardiology
Sankt Gallen
Bürgerspital Solothurn Cardiology
Solothurn
Stadtspital Triemli
Zurich
University Hospital Zürich Cardiology
Zurich
Time Frame
Start Date: 2021-03-31
Completion Date: 2027-11-30
Participants
Target number of participants: 200
Authors
Tilmann Perrin
Sponsors
Leads: Raban Jeger

This content was sourced from clinicaltrials.gov