Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

NCT04881578 | Active Not Recruiting

• 1 other identifier: 2021-00016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Cryptogenic Stroke; Foramen Ovale, Patent; Atrial Fibrillation

Keywords

occlusion of patent foramen ovale

Outcome Measures

Primary Outcomes (1)

• incidence of first AF within 12 months after percutaneous PFO occlusion

  to assess the incidence of first AF within 12 months after percutaneous PFO closure with a prespecified landmark analysis after 3 months to differentiate potentially device related AF (months 0-3) from likely intrinsic AF (months 4-12)

  12 months

Secondary Outcomes (8)

• Incidence of first AF within 3 months of continuous rhythm monitoring before the intended percutaneous PFO closure procedure

  3 months

• Overall incidence of first AF from ICM-implantation to ICM-explantation or 36 months post implantation (if ICM remains in situ) excluding a blanking period of the first 3 months after PFO closure

  36 months

• Differences in the primary endpoint according to the grade of the PFO

  12 months

• Incidence of recurrent clinical embolic events such as cryptogenic strokes or systemic embolism including pulmonary embolism (with the use of the TOAST classification algorithm)

  36 months

• AF burden, defined as proportion of follow-up time with documented AF at different time points

  36 months

Interventions

continuous cardiac monitoring before and after transcatheter PFO closure OTHER

Data will be assessed from patients with cryptogenic stroke and planned PFO occlusion who undergo the contemporary ICM protocols to search for silent AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with a history of systemic embolization, i.e., cryptogenic stroke or acute peripheral arterial closures, and a concomitant PFO

You may qualify if:

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

You may not qualify if:

• Known etiology of the embolic event (based on neuro-/cardiac/vascular imaging), such as:
• Evidence of large-artery atherosclerosis (ultrasonography, CT or MRI angiography, or digital subtraction angiography) with stenosis of 50% or more in the artery feeding the acute ischemic territory.
• Small vessel disease, defined by radiographic appearance consistent with ischemic infarction in the territory of a perforating arteriole, with ≤20 mm in diameter on axial sections and not involving the cortex, located in the white matter, internal or external capsule, deep brain nuclei, thalamus, or brainstem.
• Evidence of a high-risk cardiac or aortic arch source of embolism (left ventricular or left atrial thrombus or "smoke," emboligenic valvular lesion or tumor, aortic arch plaque \>3 mm thick or with mobile components or any other high-risk lesion)
• Stroke of other determined cause such as presence of non-atherosclerotic vasculopathies (i.e. dissection, fibromuscular dysplasia), hypercoagulable states (must be tested in patients \<55 years old) and hematologic disorders
• Atrial septal defect or ventricular septal defect.
• Coronary or valvular disease requiring surgical intervention.
• Documented history of AF or atrial flutter.
• Permanent indication for therapeutic oral anticoagulation at enrollment.
• Already included in another clinical trial that will affect the objectives of this study.
• Life expectancy \<1 year.
• Pregnancy.
• Patient underwent or is scheduled for implantation of a pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device.
• Unable or unwilling to follow the required procedures of the Clinical Investigation Plan.

Sponsors & Collaborators

• Raban Jeger: lead

Study Sites (6)

Stadtspital Triemli

Zurich, Canton of Zurich, 8063, Switzerland

Location

University Hospital Basel, Heart Center

Basel, 4053, Switzerland

Location

University Hospital Bern Inselspital Cardiology

Bern, Switzerland

Location

Cantonal Hospital St.Gallen Cardiology

Sankt Gallen, 9007, Switzerland

Location

Bürgerspital Solothurn Cardiology

Solothurn, 4500, Switzerland

Location

University Hospital Zürich Cardiology

Zurich, 8006, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke; Foramen Ovale, Patent; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raban Jeger, Prof Dr med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Tobias Reichlin, Prof Dr med

  University Hospital Bern Inselspital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: March 31, 2021
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6)