An interventional study of PFO Closure Rate and Published PFO Device Closure in Foramen Ovale, Patent, Septal Defect, Atrial and Septal Defect, Heart, sponsored by HeartStitch.Com. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-14.
Sponsored by HeartStitch.Com · Not applicable, Interventional, and Treatment
Among 36 studies in Foramen Ovale, Patent with a site in United States — 10 open to participants now, 12 under way, 1 of them phase 3. Foramen Ovale, Patent · United States.
Among the 36 studies in Foramen Ovale, Patent with a site in United States, this one is the 11th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2017, is one of 15 with no phase, and was the 19th registered.
136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.
Browse Foramen Ovale, Patent studies →10 of the 36 studies in Foramen Ovale, Patent with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Tufts Medical Center · Sites in United States
Scripps Health · Sites in United States
Recross Cardio, Inc. · Sites in United States
Abbott Medical Devices · Sites in United States, Denmark, Estonia and 7 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 34 Foramen Ovale, Patent studies recruiting now, 11 (32%) set no upper age limit and 19 (56%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 6 · Phase 4 1
First in 1993; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 250 is above the median of 154 across 69 interventional studies indexed under Foramen Ovale, Patent.
Median enrollment 168 across the 25 interventional studies, 256 across the 11 observational. Of the 17 that completed or were terminated, 8 (47%) have results posted.
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22 of 36 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with HeartStitch.Com as lead sponsor.
HeartStitch.Com has 1 study filed under Foramen Ovale, Patent — fewer than ten, so there is no comparison to draw.
2 of the studies in Foramen Ovale, Patent with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04339699Nobles Medical Technologies II IncNobleStitch EL STITCH Trial is a PFO Comparative Trial | 2026-12-31 |
| NCT07420400Scripps HealthNon-Invasive Detection of Right-to-Left Cardiac Shunts | 2027-01-01 |
Among the 36 studies in Foramen Ovale, Patent with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Device: PFO Closure Rate · Device: Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Suture Mediated PFO Closure and Septal Repair
Closure Rates of PFO and ASD
Saline Contrast Echo
Time frame: 12 months
Recurrent Stroke Rate
Rate of which Patient Experiences Recurrent Stroke
Time frame: 4-6 weeks, 6 months, 1 year and annually up to five years
Migraine
Rate of Patients who have Experienced Improvement in Migraine
Time frame: 4-6 weeks, 6 months, 1 year and annually up to five years
Started Nov 2017 (actual). Primary completion is estimated for Nov 2019, 24 months after the start.
Of 31 interventional studies with no phase under Foramen Ovale, Patent, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 100. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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