NobleStitch™ EL vs Amplatzer for Patent Foramen Ovale

(STITCH Trial)

Recruiting at 7 trial locations

Overseen By Anthony Nobles, Phd

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nobles Medical Technologies II Inc

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Myocardial infarction, Diabetes, Hypertension, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices to determine which better closes a small hole in the heart called a Patent Foramen Ovale (PFO). Closing this hole may help prevent future strokes in individuals who have experienced a cryptogenic stroke. The trial compares the NobleStitch EL, a suture-based device, with the Amplatzer PFO Occluder, a plug-like device. It seeks participants who have had a PFO and a previous stroke, verified by a neurologist. Participants should have experienced stroke symptoms lasting at least 24 hours or shorter with evidence of brain impact on imaging. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance future stroke prevention strategies.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you require chronic anticoagulation therapy that cannot be discontinued, you may not be eligible to participate.

What prior data suggests that these devices are safe for closing Patent Foramen Ovale?

Research has shown that both the NobleStitch EL and the Amplatzer PFO Occluder are safe, based on previous studies.

For the Amplatzer PFO Occluder, studies have found it effectively lowers the chance of another stroke. One important study showed that the risk of a repeat stroke was only 1.5% over nine years. Most patients handled the procedure well, and the device was successfully implanted in many cases.

The NobleStitch EL has also proven to be very safe. In a large study that followed patients for four years, there were no complications or strokes related to the device. The procedure was successful in over 90% of cases, indicating it is generally well-tolerated.

Both treatments have strong safety records from past research, suggesting they are good options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NobleStitch EL Suture Mediated Closure System because it offers a minimally invasive approach to closing a patent foramen ovale (PFO), a small hole in the heart that can lead to strokes. Unlike the standard of care, which often involves using devices like the Amplatzer PFO Occluder that remain in the heart as implants, NobleStitch EL uses a suture-mediated technique to close the PFO without leaving any permanent material behind. This could potentially reduce the risk of complications associated with implanted devices and make the recovery process smoother for patients.

What evidence suggests that this trial's treatments could be effective for preventing recurrent ischemic stroke?

This trial will compare the Amplatzer PFO Occluder and the NobleStitch EL Suture Mediated Closure System. Studies have shown that the Amplatzer PFO Occluder effectively prevents repeat strokes, with only a 1.5% chance of another stroke over nine years after use. Extensive testing has provided strong evidence of its success in closing a patent foramen ovale (PFO), a small hole in the heart that can cause strokes.

Research indicates that the NobleStitch EL successfully closed the PFO in 94% of cases, with no new strokes reported in a study of 703 patients over four years. The device demonstrates a high rate of correct placement and no device-related issues, such as irregular heartbeat. While both treatments in this trial aim to close the PFO to prevent strokes, each has shown promising results in different ways. ^{4 6 7 8 9}

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?

Inclusion Criteria

Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either: Symptoms persisting ≥24 hours, or Symptoms persisting <24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct Cryptogenic stroke was defined as a stroke of unknown cause

Cryptogenic stroke means that the cause of your stroke is unknown.

Provision of signed and dated informed consent form

Exclusion Criteria

Female participant who is pregnant, lactating or planning a pregnancy during the course of the study

Previous myocardial infarction or unstable angina within 6 months

Clinically significant mitral or aortic valve stenosis or severe regurgitation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the NobleStitch EL or Amplatzer PFO Occluder device for PFO closure

6 months

Multiple visits for device implantation and initial follow-up

Follow-up

Participants are monitored for safety and effectiveness, including the occurrence of recurrent ischemic stroke

5 years

Regular follow-up visits over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Amplatzer PFO Occluder
• NobleStitch EL Suture Mediated Closure System

How Is the Trial Designed?

Group I: NobleStitch™EL Active Control 1 Intervention

Participants treated with the NobleStitch™EL device

Group II: Amplatzer PFO Occluder Active Control 1 Intervention

Participants treated with the Amplatzer PFO Occluder device

Who Is Running the Clinical Trial?

Nobles Medical Technologies II Inc

Lead Sponsor

Trials

2

Recruited

1,300+

HeartStitch.Com

Lead Sponsor

Trials

2

Recruited

890+

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.

cardiovascular.abbott

cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-talisman.html

Amplatzer Talisman PFO Occluder | PFO Closure Device

And our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.3. With the introduction of the ...

4.

fda.gov

fda.gov/media/97972/download

AMPLATZERTM PFO Occluder

The RESPECT trial, along with the pooled meta-analysis, showed that closure of the PFO with the. AMPLATZER PFO Occluder is effective in reducing the rate of ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S091450872100280X

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 for PFO patients ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf12/p120021b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED)

The AMPLATZER PFO. Occluder met the requirements for establishing pre-clinical safety and performance. Complete PFO closure and device ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30741039/

Amplatzer patent foramen ovale occluder: safety and efficacy

Randomized studies have proved its benefit for prevention of recurrent ischemic events (particularly strokes) in patients without competing stroke etiology.

8.

structuralheart.abbott

structuralheart.abbott/products/pfo-closure-device/amplatzer-pfo-closure-clinical-data

Amplatzer Talisman PFO Occluder Clinical Data

Excellent safety · Significantly lower risk of recurrent stroke. The RESPECT trial revealed a 62% relative risk reduction for recurrent cryptogenic ischemic ...

9.

jacc.org

jacc.org/doi/10.1016/j.jacc.2025.09.407

TCT-305 The Landmark RESPECT Results Reaffirmed ...

Conscious sedation was common (88%), procedures brief (median: 25 min PFO; 21 min Talisman), and 98% discharged same/next day. Implant success was 99.2% (69% ...