Treatment for Septal Defect, Heart

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tampa General Hospital, Tampa, FL
Septal Defect, Heart+4 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new device can prevent recurrent ischemic stroke.

See full description

Eligible Conditions

  • Septal Defect, Heart
  • Foramen Ovale, Patent
  • Atrial Septal Defect (ASD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Septal Defect, Heart. Measurement will happen over the course of 12 months.

12 months
Closure Rates of PFO and ASD
Year 1
Migraine
Year 1
Recurrent Stroke Rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Published PFO Device Closure
1 of 1
Active Control

This trial requires 640 total participants across 1 different treatment group

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Published PFO Device Closure
Device
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4-6 weeks, 6 months, 1 year, and annualy up to five years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4-6 weeks, 6 months, 1 year, and annualy up to five years for reporting.

Closest Location

Tampa General Hospital - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Septal Defect, Heart or one of the other 4 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If an appropriate patent foramen ovale (PFO) or small atrial septal defect (ASD) is present, a hole should be created between the atria (the two upper chambers of the heart). show original
A syndrome that is marked by platypnea and orthodeoxia show original
PFO
The patient has an ASD that is less than 1 cm wide and has redundant septal tissue. show original
The trans septal puncture sites are located on either side of the septum, just above the upper lip. show original
Stroke
A transient ischemic attack (TIA) is a mini-stroke show original
Decompression Illness

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Septal Defect, Heart by sharing your contact details with the study coordinator.