640 Participants Needed

Device Closure for Patent Foramen Ovale

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nobles Medical Technologies II Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent ischemic stroke.

Research Team

AA

Anthony A Nobles, PhD

Principal Investigator

Nobles Medical Technologies II Inc

Eligibility Criteria

The STITCH trial is for adults aged 18-65 with specific heart conditions: small Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO). It's suitable for those who've had a stroke, transient ischemic attack (TIA), or certain decompression illnesses. People under 18, over 65, or not fluent in English can't participate.

Inclusion Criteria

Sites where the septum (wall between the heart's chambers) has been punctured.
You have an atrial septal defect (ASD) that is smaller than 1 cm with extra tissue.
This criterion refers to the presence of a patent foramen ovale (PFO), which is a small hole in the heart that didn't close the way it should after birth.
See 5 more

Exclusion Criteria

I am between 18 and 65 years old.
I am not fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PFO closure using the NobleStitch™ EL or Amplatzer Occluder device

4-6 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of migraine improvement and recurrent stroke rate

5 years
Visits at 6 months, 1 year, and annually

Treatment Details

Interventions

  • Amplatzer
  • NobleStitch EL
Trial OverviewThis study compares two devices used to repair heart defects that can lead to strokes. The NobleStitch EL and the FDA-approved Amplatzer Occluder are being tested on their effectiveness in closing PFOs and preventing recurrent strokes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PFO Closure RateExperimental Treatment1 Intervention
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), transseptal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present), and rate of a recurrent neurologic embolic event in patients with cryptogenic stroke and PFO.
Group II: Published PFO Device ClosureActive Control1 Intervention
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nobles Medical Technologies II Inc

Lead Sponsor

Trials
2
Recruited
1,300+