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Device

Published PFO Device Closure for Patent Foramen Ovale (STITCH Trial)

N/A
Waitlist Available
Led By James Thompson, MD
Research Sponsored by HeartStitch.Com
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks, 6 months, 1 year and annually up to five years
Awards & highlights

STITCH Trial Summary

This trial is looking at whether a specific type of surgery can help prevent strokes in people with a heart condition.

Eligible Conditions
  • Patent Foramen Ovale
  • Atrial Septal Defect

STITCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks, 6 months, 1 year and annually up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks, 6 months, 1 year and annually up to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Closure Rates of PFO and ASD
Secondary outcome measures
Recurrent Stroke Rate
Other outcome measures
Migraine

STITCH Trial Design

2Treatment groups
Experimental Treatment
Group I: Published PFO Device ClosureExperimental Treatment2 Interventions
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Group II: PFO Closure RateExperimental Treatment2 Interventions
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

Find a Location

Who is running the clinical trial?

HeartStitch.ComLead Sponsor
1 Previous Clinical Trials
640 Total Patients Enrolled
James Thompson, MDPrincipal InvestigatorInova Cardiovascular Institute
2 Previous Clinical Trials
84 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Stitch Closure of PFO and Septal Repair
James Thompson, MD 2017. "Stitch Closure of PFO and Septal Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03373929.
~34 spots leftby Apr 2025
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