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Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study (ALFA ROMEO)

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ClinicalTrials.gov Identifier: NCT04881578
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Raban Jeger, University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment
Cryptogenic Stroke Foramen Ovale, Patent Atrial Fibrillation Other: continuous cardiac monitoring before and after transcatheter PFO closure

Detailed 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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. incidence of first AF within 12 months after percutaneous PFO occlusion [ Time Frame: 12 months ]
    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)


Secondary Outcome Measures :
  1. Incidence of first AF within 3 months of continuous rhythm monitoring before the intended percutaneous PFO closure procedure [ Time Frame: 3 months ]
  2. 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 [ Time Frame: 36 months ]
  3. Differences in the primary endpoint according to the grade of the PFO [ Time Frame: 12 months ]
  4. Incidence of recurrent clinical embolic events such as cryptogenic strokes or systemic embolism including pulmonary embolism (with the use of the TOAST classification algorithm) [ Time Frame: 36 months ]
  5. AF burden, defined as proportion of follow-up time with documented AF at different time points [ Time Frame: 36 months ]
  6. Incidence of major bleeding (BARC 3 to 5) [ Time Frame: 36 months ]
  7. Incidence of any death and cardiovascular death at different timepoints [ Time Frame: 36 months ]
  8. Device related events [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881578


Contacts
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Contact: Raban Jeger, Prof Dr med +41 61 265 25 25 raban.jeger@usb.ch
Contact: Nicole Gilgen, Dr med +41 61 265 25 25 nicole.gilgen@usb.ch

Locations
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Switzerland
Cantonal Hospital Aarau Cardiology Recruiting
Aarau, Switzerland, 5001
Contact: Miriam Brinkert, Dr med    +41 62 838 41 41    miriam.brinkert@ksa.ch   
University Hospital Basel, Heart Center Recruiting
Basel, Switzerland, 4053
Contact: Raban Jeger, Prof Dr med    +41 61 265 25 25    raban.jeger@usb.ch   
Contact: Nicole Gilgen, Dr med    +41 61 265 25 25    nicole.gilgen@usb.ch   
University Hospital Bern Inselspital Cardiology Recruiting
Bern, Switzerland
Contact: Tobias Reichlin, Prof Dr med    +41 31 632 21 11    tobias.reichlin@insel.ch   
Bürgerspital Solothurn Cardiology Recruiting
Solothurn, Switzerland, 4500
Contact: Rolf Vogel, Prof Dr med et phil nat    +41 32 627 31 21    Rolf.Vogel@spital.so.ch   
Sub-Investigator: Tilmann Perrin, Dr med         
Cantonal Hospital St.Gallen Cardiology Recruiting
St.gallen, Switzerland, 9007
Contact: Daniel Weilenmann, Dr med    +41 71 494 11 11    Daniel.Weilenmann@kssg.ch   
University Hospital Zürich Cardiology Recruiting
Zürich, Switzerland, 8006
Contact: Alexander Breitenstein, PD Dr med    141 44 255 11 11    Alexander.Breitenstein@usz.ch   
Sponsors and Collaborators
Raban Jeger
Investigators
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Principal Investigator: Raban Jeger, Prof Dr med University Hospital, Basel, Switzerland
Principal Investigator: Tobias Reichlin, Prof Dr med University Hospital Bern Inselspital, Switzerland
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Responsible Party: Raban Jeger, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04881578    
Other Study ID Numbers: 2021-00016
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raban Jeger, University Hospital, Basel, Switzerland:
occlusion of patent foramen ovale
Additional relevant MeSH terms:
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Ischemic Stroke
Atrial Fibrillation
Foramen Ovale, Patent
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases