Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

Atrial Fibrillation Clinical Trial

— ALFA ROMEO  

Official title:

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881578
• Other study ID #: 2021-00016
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raban Jeger, Prof Dr med
• Phone: +41 61 265 25 25
• Email: raban.jeger[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

For patients with cryptogenic stroke and PFO, a better understanding of the exact incidence of new-onset AF before and after PFO closure, its occurrence during follow-up, its persistence or reversibility and its prognostic impact is critical: If only a PFO, but no AF is available, then PFO closure followed by a limited duration of antiplatelet therapy is indicated. If on the other hand side a PFO and AF is found, lifelong therapeutic anticoagulation is mandatory.

By using the contemporary ICM protocols to search for silent AF in patients with cryptogenic stroke and a PFO for 3 months before PFO closure, ALFA ROMEO will help to understand the relationship of silent and previously undetected AF in the setting of PFO and investigate the true incidence of new-onset AF and its temporal course after effective PFO closure. Our findings will have the potential to impact on the future diagnostic and therapeutic management of patients with cryptogenic stroke and a PFO

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Cardiac monitoring is planned to be performed with the BIOMONITOR III(m) device

3. 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.

4. Occlusion of PFO is planned to be performed with the AMPLATZERTM PFO OCCLUDER device.

5. Patient is willing to sign patient consent form.

6. Age =18 years.

Exclusion Criteria:

1. 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

2. Atrial septal defect or ventricular septal defect.

3. Coronary or valvular disease requiring surgical intervention.

4. Documented history of AF or atrial flutter.

5. Permanent indication for therapeutic oral anticoagulation at enrollment.

6. Already included in another clinical trial that will affect the objectives of this study.

7. Life expectancy <1 year.

8. Pregnancy.

9. Patient underwent or is scheduled for implantation of a pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device.

10. Unable or unwilling to follow the required procedures of the Clinical Investigation Plan.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke
• Foramen Ovale, Patent
• Ischemic Stroke

Intervention

Other:
• continuous cardiac monitoring before and after transcatheter PFO closure
Data will be assessed from patients with cryptogenic stroke and planned PFO occlusion who undergo the contemporary ICM protocols to search for silent AF

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Aarau Cardiology	Aarau
Switzerland	University Hospital Basel, Heart Center	Basel
Switzerland	University Hospital Bern Inselspital Cardiology	Bern
Switzerland	Bürgerspital Solothurn Cardiology	Solothurn
Switzerland	Cantonal Hospital St.Gallen Cardiology	St.gallen
Switzerland	Stadtspital Triemli	Zürich
Switzerland	University Hospital Zürich Cardiology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Raban Jeger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of first AF within 3 months of continuous rhythm monitoring before the intended percutaneous PFO closure procedure		3 months
Secondary	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
Secondary	Differences in the primary endpoint according to the grade of the PFO		12 months
Secondary	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
Secondary	AF burden, defined as proportion of follow-up time with documented AF at different time points		36 months
Secondary	Incidence of major bleeding (BARC 3 to 5)		36 months
Secondary	Incidence of any death and cardiovascular death at different timepoints		36 months
Secondary	Device related events		36 months