Device Closure for Patent Foramen Ovale

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nobles Medical Technologies II Inc

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4-6 weeks

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices, the Amplatzer and NobleStitch EL, to determine which is more effective at closing a hole in the heart called a Patent Foramen Ovale (PFO). Closing a PFO can help prevent strokes caused by blood clots passing through this hole. The trial seeks individuals who have experienced a stroke or mini-stroke and have a PFO or similar heart conditions. Participants will assist researchers in comparing the effectiveness and safety of these two devices in closing the heart defect. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance future heart treatments.

What prior data suggests that these devices are safe for PFO closure?

Research has shown that both the Amplatzer and NobleStitch EL devices are promising for safely closing a Patent Foramen Ovale (PFO), an opening in the heart that should close after birth.

For the Amplatzer device, studies indicate it is very safe, with only about a 1.5% chance of stroke recurrence over nine years post-procedure. Most people tolerate the device well, although those with nickel allergies might experience some issues.

The NobleStitch EL device also has a strong safety record. Recent data show no device-related problems, such as irregular heartbeat or repeated strokes, in a large group of patients, suggesting it is well-tolerated over time.

Both devices have been studied for their ability to safely close the PFO and prevent future strokes. The evidence so far supports their safety for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments Amplatzer and NobleStitch EL because they offer unique methods for closing patent foramen ovale (PFO), which is a hole in the heart that didn't close the way it should after birth. Unlike most standard treatments that involve more invasive surgical procedures, these devices provide a minimally invasive approach. The Amplatzer device acts like a tiny plug that seals the hole, while the NobleStitch EL uses a stitch-based technique to close the PFO. These innovative methods aim to improve patient outcomes by reducing recovery times and potentially lowering the risk of complications compared to traditional surgical options.

What evidence suggests that these devices are effective for closing Patent Foramen Ovale?

This trial will compare the effectiveness of two devices for closing a patent foramen ovale (PFO): the Amplatzer PFO Occluder and the NobleStitch EL. Research has shown that the Amplatzer PFO Occluder effectively closes PFOs in 98.9% of cases without major complications, reducing the risk of another stroke to 1.5% over nine years. Meanwhile, studies indicate that the NobleStitch EL closes PFOs in 94% of patients with good positioning, achieving a closure rate of 89% and complete closure in 75% of cases. Both devices show promise in preventing future strokes in patients with PFOs. ^{1 2 3 6 7}

Who Is on the Research Team?

Anthony A Nobles, PhD

Principal Investigator

Nobles Medical Technologies II Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Sites where the septum (wall between the heart's chambers) has been punctured.

You have an atrial septal defect (ASD) that is smaller than 1 cm with extra tissue.

This criterion refers to the presence of a patent foramen ovale (PFO), which is a small hole in the heart that didn't close the way it should after birth.

Exclusion Criteria

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PFO closure using the NobleStitch™ EL or Amplatzer Occluder device

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of migraine improvement and recurrent stroke rate

5 years

Visits at 6 months, 1 year, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Amplatzer
• NobleStitch EL

Trial Overview 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.

How Is the Trial Designed?

Group I: PFO Closure Rate Experimental Treatment 1 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 Closure Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Nobles Medical Technologies II Inc

Lead Sponsor

Trials

2

Recruited

1,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36165815/

Real world long-term outcomes among adults undergoing ... We observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322013833

Real world long-term outcomes among adults undergoing ... In this study, the risk of recurrent stroke at 9 years follow-up post PFO closure with Amplatzer PFO Occluder was 1.5%.

3. jacc.org jacc.org/doi/10.1016/j.jacadv.2023.100257

Outcomes of Patent Foramen Ovale Transcatheter Closure Over the study period, 324 patients underwent PFO closure with the Amplatzer PFO device, with a mean age of 49.8 years; 61% had a short aortic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34772575/

Cost-effectiveness analysis of patent foramen ovale ... Conclusion: Amplatzer plus MT represents a cost-effective treatment option and is associated with lower stroke recurrence compared to MT alone ...

5. mdpi.com mdpi.com/2077-0383/13/21/6354

Comparative Effectiveness of Devices for Interventional ... The overall initial procedural success rate was 98.9%, indicating that the vast majority of PFO closure procedures were completed without major ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5699514/

Safety Outcomes After Percutaneous Transcatheter ... Observational data suggest that percutaneous transcatheter closure of PFO for secondary stroke prevention is safe and effective; however, three recent ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015228

Patent Foramen Ovale Closure in Patients With and ... Patients with nickel hypersensitivity are at significantly higher risk of developing device syndrome after patent foramen ovale closure.