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Procedure

Device Closure for Patent Foramen Ovale

N/A
Waitlist Available
Research Sponsored by Nobles Medical Technologies II Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Decompression Illness
Stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks, 6 months, 1 year, and annualy up to five years
Awards & highlights

Study Summary

This trial is comparing two devices for closing a hole in the heart that is linked to recurrent strokes.

Who is the study for?
The STITCH trial is for adults aged 18-65 with specific heart conditions: small Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO). It's suitable for those who've had a stroke, transient ischemic attack (TIA), or certain decompression illnesses. People under 18, over 65, or not fluent in English can't participate.Check my eligibility
What is being tested?
This study compares two devices used to repair heart defects that can lead to strokes. The NobleStitch EL and the FDA-approved Amplatzer Occluder are being tested on their effectiveness in closing PFOs and preventing recurrent strokes.See study design
What are the potential side effects?
Potential side effects may include discomfort at the puncture site, bleeding, allergic reactions to device materials, irregular heartbeat during the procedure, and risks associated with heart catheterization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had decompression sickness.
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I have had a stroke.
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I have had a transient ischemic attack.
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I have been diagnosed with Platypnea-Orthodeoxia Syndrome.

Timeline

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PFO Closure RateExperimental Treatment1 Intervention
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), transseptal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present), and rate of a recurrent neurologic embolic event in patients with cryptogenic stroke and PFO.
Group II: Published PFO Device ClosureActive Control1 Intervention
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials

Find a Location

Who is running the clinical trial?

Nobles Medical Technologies II IncLead Sponsor
1 Previous Clinical Trials
640 Total Patients Enrolled
Anthony A Nobles, PhDStudy DirectorNobles Medical Technologies II Inc
1 Previous Clinical Trials
640 Total Patients Enrolled

Media Library

Amplatzer (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05025475 — N/A
Atrial Septal Defect Research Study Groups: PFO Closure Rate, Published PFO Device Closure
Atrial Septal Defect Clinical Trial 2023: Amplatzer Highlights & Side Effects. Trial Name: NCT05025475 — N/A
Amplatzer (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025475 — N/A

Frequently Asked Questions

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

Is the opportunity to take part in this experiment open to me?

"This clinical trial requires 640 participants between 18 and 65 years old with a septal defect in the heart. They must also possess an ASD of less than 1 cm, trans-septal puncture sites, as well as experience from decompression sickness."

Answered by AI

Are adults eligible to join this experiment?

"The eligibility requirements for this trial dictate that prospective patients are between 18 and 65 years old. Separately, there exist 10 studies dedicated to those below the age of majority and 22 for seniors aged over 65."

Answered by AI

Is the current study seeking participants?

"According to clinicaltrials.gov, the trial posted on January 1st 2021 is not currently accepting applicants. The last update was made in August 2nd 2022. At present, there are 34 other medical studies actively searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Tampa General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Stitch Closure of PFO and Septal Repair (STITCH)
2021. "Stitch Closure of PFO and Septal Repair (STITCH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025475.
~31 spots leftby Jun 2024
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