Stitch Closure of PFO and Septal Repair

Not Applicable

• Conditions: Septal Defect, Atrial; Foramen Ovale, Patent; Septal Defect, Heart
• Interventions: Device: PFO Closure Rate; Device: Published PFO Device Closure

• Registration Number: NCT03373929
• Lead Sponsor: HeartStitch.Com

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Primary Completion: 2019-11-20
• Study Completion: 2022-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PFO Closure Rate	Published PFO Device Closure	Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO
Published PFO Device Closure	PFO Closure Rate	Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Published PFO Device Closure	Published PFO Device Closure	Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
PFO Closure Rate	PFO Closure Rate	Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO

Primary Outcome Measures

Name	Time	Method
Closure Rates of PFO and ASD	12 months	Saline Contrast Echo

Secondary Outcome Measures

Name	Time	Method
Recurrent Stroke Rate	4-6 weeks, 6 months, 1 year and annually up to five years	Rate of which Patient Experiences Recurrent Stroke

Trial Locations

Locations (1)

Inova Cardiovascular Institute; 🇺🇸 Falls Church, Virginia, United States