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Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System (HeartStitch)

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03373929

Background Information

The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.

Offered At

Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, VA 22042 

Principal Investigator

Jim Thompson, MD

Eligibility Information

  • PFO
  • ASD (less than 1 cm with redundant septal tissue)
  • Trans Septal Puncture Sites
  • ASA (when an appropriate PFO or small ASD defect is present)
  • Stroke
  • Trans ischemic Attack (TIA)
  • Platypnea Orthodeoxia Syndrome
  • Decompression Illness
  • Migraines

Ineligibility Information

Exclusion Criteria:

  • Patients under 18 and over 65
  • Patients who are not fluent in English