NCT03373929

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 6, 2017

Last Update Submit

December 11, 2017

Conditions

Foramen Ovale, PatentSeptal Defect, AtrialSeptal Defect, Heart

Outcome Measures

Primary Outcomes (1)

  • Closure Rates of PFO and ASD

    Saline Contrast Echo

    12 months

Secondary Outcomes (1)

  • Recurrent Stroke Rate

    4-6 weeks, 6 months, 1 year and annually up to five years

Other Outcomes (1)

  • Migraine

    4-6 weeks, 6 months, 1 year and annually up to five years

Study Arms (2)

PFO Closure Rate

OTHER

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 RateDevice: Published PFO Device Closure

Published PFO Device Closure

OTHER

Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.

Device: PFO Closure RateDevice: Published PFO Device Closure

Interventions

PFO Closure RateDEVICE

Suture Mediated PFO Closure and Septal Repair

PFO Closure RatePublished PFO Device Closure
Published PFO Device ClosureDEVICE

Suture Mediated PFO Closure and Septal Repair

PFO Closure RatePublished PFO Device Closure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Cardiovascular Institute

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Foramen Ovale, PatentHeart Septal Defects, AtrialHeart Septal Defects

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • James Thompson, MD

    Inova Cardiovascular Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Non-randomized, single-center, observational study
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 14, 2017

Study Start

November 20, 2017

Primary Completion

November 20, 2019

Study Completion

November 20, 2022

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

US(1)