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NobleStitch EL STITCH Trial for PFO Closure

This study is comparing two ways to close a Patent Foramen Ovale (PFO), which is a small opening between the upper chambers of the heart that didn't close naturally after birth. Sometimes, a PFO can be linked to an ischemic stroke (a stroke caused by a blood clot). The study is testing the NobleStitch™EL Suture Mediated Closure System against the Amplatzer PFO Occluder. Both are devices used to close the PFO without open-heart surgery. Researchers want to see if the NobleStitch EL is as safe and effective as the Amplatzer PFO Occluder in preventing future strokes. You might be able to join if you are between 18 and 60 years old, have a PFO, and have experienced a cryptogenic stroke (a stroke with no clear cause). The study aims to enroll 640 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two devices for PFO closure. It aims to enroll 640 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, effective PFO closure, will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04339699

NobleStitch EL STITCH Trial is a PFO Comparative Trial

Recruiting
NAAges 18–60InterventionalTreatment
Nobles Medical Technologies II Inc
~640 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:NobleStitch™EL Suture Mediated Closure SystemAmplatzer PFO Occluder

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effective PFO closure rate of the NobleStitch EL
Measured over 6 months

Conditions

Foramen Ovale, Patent
Stroke, Ischemic

Explore related trials

Ischemic StrokePatent Foramen Ovale

Where it's being run

2 sites across 2 states
Arizona1
Lazio1

Study leadership

  • Anthony A Nobles, PhD · STUDY_DIRECTOR · Nobles Medical Technologies II Inc

Who to contact

James A Thompson, MD
[email protected]
727-767-7328
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female ages 18 - 60 years old
A PFO and a Cryptogenic Stroke verified by a neurologist
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 Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct
Cryptogenic stroke was defined as a stroke of unknown cause
Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
Hypercoagulable state assessment to rule out an underlying hypercoagulable state

Exclusion

Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
Age \<18 or \> 60 years of age
Previous myocardial infarction or unstable angina within 6 months
Clinically significant mitral or aortic valve stenosis or severe regurgitation
Left Ventricular Ejection Fraction \<50 percent
Progressive neurological dysfunction or reduced life expectancy
Contrast allergy
Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases
Active Endocarditis
Perspective participants with known causes of Ischemic Stroke
Arterial dissection
Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
Perspective participants with prosthetic heart valves
Uncontrolled diabetes Mellitus
Pulmonary hypertension
Uncontrolled systemic hypertension
Intracranial pathology
Neurological deficits not due to stroke that may affect neurologic assessments
Active autoimmune disease
Active infection
Alcohol and/or drug abuse
A requirement for chronic anticoagulation therapy that cannot be discontinued
Anatomic features (inability to achieve vascular access)

What this trial measures

  • Effective PFO closure rate of the NobleStitch EL6 months

    Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts