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Stitch Closure of PFO and Septal Repair

NCT03373929 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-12-14

No results posted yet for this study

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.

Conditions

  • Foramen Ovale, Patent
  • Septal Defect, Atrial
  • Septal Defect, Heart

Interventions

DEVICE

PFO Closure Rate

Suture Mediated PFO Closure and Septal Repair

DEVICE

Published PFO Device Closure

Suture Mediated PFO Closure and Septal Repair

Sponsors & Collaborators

  • HeartStitch.Com

    lead INDUSTRY

Principal Investigators

  • James Thompson, MD · Inova Cardiovascular Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2019-11-20
Completion
2022-11-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373929 on ClinicalTrials.gov