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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

Must not have

Patients under 18 years and over 65 years of age

Patients who are not fluent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 weeks, 6 months, 1 year, and annualy up to five years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am between 18 and 65 years old.

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 weeks, 6 months, 1 year, and annualy up to five years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Closure Rates of PFO and ASD

Secondary study objectives

Recurrent Stroke Rate

Other study objectives

Migraine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met