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Recruiting NCT05537753

Encore PFO Closure Device - The PerFOrm Trial

No phase Interventional Patent Foramen Ovale Cryptogenic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Encore PFO closure device, FDA-approved PFO closure device.
Who it may be relevant to
Registry conditions: Patent Foramen Ovale, Cryptogenic Stroke. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial

Overview

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Detailed description

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Interventions

  • Device Encore PFO closure device
    The Encore PFO closure device comprises an implant component and a single-use delivery system.
  • Device FDA-approved PFO closure device
    Chosen by the investigator

Primary outcome measures

  • Safety: The incidence of device- or procedure-related serious adverse events (SAEs) [Time frame: 6 months]
  • Effectiveness: Effective closure [Time frame: 6 months]
Secondary outcome measures (6)
  • Complete closure [Time frame: 6 months]
  • Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death [Time frame: 5 years]
  • Occurrence of transient ischemic attacks (TIA) [Time frame: 5 years]
  • Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation) [Time frame: 5 years]
  • Occurrence of technical success [Time frame: Procedural]
  • Occurrence of procedural success [Time frame: Procedural]

Eligibility criteria

Inclusion criteria

  • Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release
  • Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct

Exclusion criteria

  • Age <18 years and age >60 years
  • Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
  • Intracardiac thrombus or tumor
  • Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
  • Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Left ventricular ejection fraction <35%
  • Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
  • Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine
  • Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
  • Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
  • Active endocarditis or other untreated infections
  • Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
  • Severe liver disease (ALT 3X ULN) or documented cirrhosis
  • Lung disease requiring continuous home oxygen
  • Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mm Hg on medication
  • Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
  • Anatomical or physiological structures that do not permit TEE
  • Anticipated need for treatment of structural cardiac defects other than PFO
  • Concomitant cardiac anomalies requiring an operative procedure
  • Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
  • Hypersensitivity to contrast medium or nickel
  • Contraindication to aspirin or clopidogrel
  • The required sheaths cannot be passed through the relevant vessels for access to the PFO
  • Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
  • Subject is unable or unwilling to provide informed consent
  • Subject is unable to comply with the protocol
  • Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Arkansas Cardiology — Little Rock
  • Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital — La Jolla
  • University of South Florida — Tampa
  • Mercy One Iowa Heart Center — West Des Moines
  • Kansas University Medical Center — Kansas City
  • Jackson Heart Clinic — Jackson
  • CHI Health — Omaha
  • Medical University of South Carolina Gazes Research Institute — Charleston

Identifiers

NCT: NCT05537753 · ENC-CL-5000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗