A Noblestitch El Stitch Trial: Prospective Multicenter Comparative Parallel Concurrent Study Of The Noblestitch El Compared To The Fda-Approved Amplatzer Occluder Device For Closure Of Patent Foramen Ovale To Prevent Recurrent Ischemic Stroke

The purpose of this study is to collect safety and effectiveness data of the use of the Noblestitch™ El suture mediated closure system to close a patent foramen ovale (PFO). These data will be compared to PFO closure using the FDA-approved amplatzer PFO occluder.

Primary:

• To investigate that the Noblestitch™ El with medical management is not inferior in both safety and effectiveness compared to the amplatzer occluder with medical management when performing PFO closure.

Secondary:

• To assess the Noblestitch™ El compared to published medical management to determine no increase in recurrent ischemic stroke.

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• An inclusion criterion is male or female ages 18-60 years old
• A PFO and a cryptogenic stroke verified by a neurologist within 270 days
• Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:
  • Symptoms persisting ≥ 24 hours, or
  • Symptoms persisting < 24 hours with MR or CT findings of a new, neuroanatomical relevant infarct
• Cryptogenic stroke was defined as a stroke of unknown cause
• PFO is defined as visualization of microbubbles in the left heart with a pattern suggestive of shunting at atrial level with a minimum of grade 2 level shunting at rest and/or with Valsalva
• Rope score of ≥ 6
• Prolonged cardiac rhythm monitoring (〜30 days) to rule out atrial fibrillation and other hear rhythm disturbances that may be associated with stroke
• Intra and extracranial artery imaging: MRA, CT angiography, or contrast angiography, or contrast angiography to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases (the aortic arch may also be evaluated by TEE)
• Hypercoagualable state assessment to rule out an underlying hypercoagulable state
• Testing may include:
  • Factor V Leidin
  • Protein C
  • Protein S
  • Antithrombin III
  • Prothrombin gene mutation
  • Plasminogen activator inhibitor
  • Homocysteine
  • Cardiolipin IGG antibody
  • Cardiolipin IGM antibody

The participant may not enter the study if any of the following apply:

• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• Age < 18 and > 60 years of age
• Previous myocardial infarction or unstable angina within 6 months
• Clinically significant mitral or aortic valve stenosis or severe regurgitation
• LVEF < 50% (with echocardiographic evaluation)
• Progressive neurological dysfunction or reduced life expectancy
• Contrast allergy
• ASD (including multi-fenestrated) or other congenital heart disease
• Endocarditis
• Criteria to exclude patients with known causes of ischemic stroke − documented paroxysmal, persistent or permanent/chronic atrial fibrillation/atrial flutter
  • LV aneurysm, intracardiac thrombus, or tumor
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding > 4 mm into the lumen
  • Atherosclerosis or arteriopathy of intra- or extracranial vessels with > 50% diameter stenosis
  • Another cause of right-to-left shunting (e.g., an ASD or a fenestrated atrial septum)
  • Presence of an arterial hypercoagulable state
  • Lacunar infarct probably due to intrinsic small vessel disease as the qualifying event, defined as an ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following:
    • A history of hypertension (except in the first week post stroke)
    • A history of diabetes mellitus
    • Age ≥ 50 years
    • MRI or CT with leukoaraiosis greater than symmetric, well-defined periventricular caps, or bands (European task force on age-related white matter changes rating scale score > 0)
• Arterial dissection as the qualifying event
• Rope score < 6
• Patients contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
• Patients with prosthetic heart valves
• Uncontrolled diabetes mellitus at the time of randomization
• Pulmonary hypertension (mean pulmonary artery pressure > 25 mmHg)
• Uncontrolled systemic hypertension
• Intracranial pathology that makes the patient inappropriate for study participation (e.g., brain tumor other than meningioma, AVM, cerebral hemorrhage, cerebral venous sinus thrombosis, or cerebral aneurysm)
• Neurological deficits not due to stroke that may affect neurologic assessments
• Active autoimmune disease (e.g., SLE, rheumatoid arthritis, polyarteritis nodosa, primary cerebral vasculitis)
• Active infection
• Alcohol and/or drug abuse
• Requirement for chronic anticoagulation therapy that cannot be discontinued
• Pulmonary AVM
• Remove ROPE Score <6
• Anatomic features identified during the screening evaluation and/or the screening TEE or ICE that are unfavorable for successful treatment with the NobleStitch™ device and/ or the Amplatzer PFO Occluder
  • Inability to achieve vascular access due to veinous access that is inadequate in size to allow safe passage of the required catheter sheath introducer for either the NobleStitch or the Amplatzer or anatomical restrictions of vessels such that would cause a “kink” in the sheath which would not allow passage of the device through the sheath.
  • Insufficient aortic rim or adequate tissue to support the NobleStitch™ device and/ or the Amplatzer PFO Occluder

For additional information, please visit: https://clinicaltrials.gov/ct2/show/NCT05025475