Stitch Closure of PFO and Septal Repair (STITCH)

December 11, 2017 updated by: James Thompson, MD, HeartStitch.Com

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Cardiovascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
Device: Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Other: Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Device: PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
Device: Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure Rates of PFO and ASD
Time Frame: 12 months
Saline Contrast Echo
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Stroke Rate
Time Frame: 4-6 weeks, 6 months, 1 year and annually up to five years
Rate of which Patient Experiences Recurrent Stroke
4-6 weeks, 6 months, 1 year and annually up to five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine
Time Frame: 4-6 weeks, 6 months, 1 year and annually up to five years
Rate of Patients who have Experienced Improvement in Migraine
4-6 weeks, 6 months, 1 year and annually up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HeartStitch.Com

Investigators

  • Principal Investigator: James Thompson, MD, Inova Cardiovascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Anticipated)

November 20, 2019

Study Completion (Anticipated)

November 20, 2022

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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