Treatment for Foramen Ovale, Patent

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Foramen Ovale, Patent+2 More
Eligibility
18+
All Sexes
Eligible conditions
Foramen Ovale, Patent

Study Summary

This study is evaluating whether a device used to treat heart defects is safe and effective in a post-approval setting.

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Eligible Conditions

  • Foramen Ovale, Patent
  • Stroke
  • Patent Foramen Ovale (PFO)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 6 secondary outcomes in patients with Foramen Ovale, Patent. Measurement will happen over the course of Index procedure.

12 months
Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
24 months
Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
Residual Shunt Characterization via assessment of shunt in patients by Echo
30 days
Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
60 months
Clinically Significant New Atrial Arrhythmia
Clinically Significant New Atrial Arrhythmia by Age
Day 1
Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)
Index procedure
Technical Success defined as successful delivery and retention of the GSO device based on physician reporting

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 636 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 months for reporting.

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Foramen Ovale, Patent or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
They had an ischemic stroke, which is presumed to have been caused by an embolic stroke of undetermined origin show original
A PFO is present if a positive bubble study shows a spontaneous right-to-left shunt or a right-to-left shunt during a Valsalva maneuver. show original
post-MI The patient is able to tolerate antiplatelet medication after a heart attack. show original
Note: Additional Inclusion Criteria may apply

Patient Q&A Section

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

What causes foramen ovale, patent?

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PFO is not a significant cause for stroke, MI, TIA, and venous thromboembolism when the PFO is closed. However, there is some evidence that the PFO is a risk factor for migraine in children.

Unverified Answer

What is foramen ovale, patent?

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In all subjects with pulmonary embolism, a patent foramen ovale should be considered. The usefulness of anticoagulation with oral warfarin is debated. Data from a recent study, patients with a patent foramen ovale, after adjustment for other risk factors, had a higher probability of developing clinical pulmonary embolism (especially non-valvular atrial fibrillation). Thus, in patients with a patent foramen ovale, the use of anticoagulation in acute pulmonary embolism is recommended.

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What are common treatments for foramen ovale, patent?

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Treatment of PFO with medical or surgical correction may not be necessary in most patients. In selected cases, closure can be effective and safe. Future research will focus on optimizing management of patients with PFO.

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Can foramen ovale, patent be cured?

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In this series, a patent septal foramen ovale was present in the majority of patients and was associated with no significant improvement in symptoms but with increased risk of thromboembolism. In a recent study, findings does not indicate that foramen ovale closure leads to improvement of symptoms.

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What are the signs of foramen ovale, patent?

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Patients with foramen ovale and/or patent should be considered for routine screening for subclinical venous thromboembolism. Patients with signs and symptoms of venous thromboembolism or who develop pulmonary emboli during testing may benefit from more thorough assessment. However, in the absence of question: Is subarachnoid hemorrhage in children associated with worse short-term outcomes than in adults? answer: Children with SAH have a higher risk of early mortality and persistent disability relative to adults.

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How many people get foramen ovale, patent a year in the United States?

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About 1% of the US population has a PFO at birth, but as many as 10% of those who develop atrial fibrillation are affected. Although AF may not occur in everyone with a PFO, a small proportion will.

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Is treatment safe for people?

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The overall number of severe or fatal AE among people undergoing percutaneous ASD closure was low and comparable to that previously reported for AVR and PTA. The safety and effectiveness of a percutaneous ASD closure compares favorably with published clinical guidelines.

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Is treatment typically used in combination with any other treatments?

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Treatment with antibiotics, immunosuppressants, interferons, and chemotherapy, along with surgical resection, were commonly used as coadministered treatment. Inclusion of any additional treatment such as surgical resection and/or chemotherapy into a treatment strategy needs to be carefully considered during long-term management of patients with an atrial septal defect because of the potential for late treatment failure.

Unverified Answer

What is the average age someone gets foramen ovale, patent?

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The age of the patient at the time of diagnosis for this condition or patent foramen ovale was 33 (with a range of 22–45) years. The majority of patients were female and it was equally distributed between right and left heart sided congenital heart disease. The number of times or methods of surgery prior to the diagnosis of foramen ovale, patent was 1 (range 0–4). The overall survival in the period from diagnosis to the death of the patients was 10 years (range 4–46).

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What are the common side effects of treatment?

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Treating patients with atrophic rhinitis in general is quite safe since they have very little effect on a healthy nose. There's a possibility of swelling of the face, but it is not permanent. Serious side effects from atrophic rhinitis treatment are usually related to surgeries. The nose and throat may get infected following surgeries which can result in permanent loss of nose function. If patients are prescribed over the counter sinonasal sprays, steroids, or antihistamines are all possible side effects. Steroid medications can result in weakened immune system that can lead to increased infections and possible infections from the medications. Antihistamines that are over the counter can cause dry mouth and difficulty in breathing due to reduced absorption.

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How does treatment work?

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The [PFO closure procedure can be performed safely and with good outcomes. We show that patients can be monitored for the first week post-operatively and have an easy referral system established to help with resolution of symptoms such as headache and flu-like symptoms. (Mundia C, 2013).

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What is treatment?

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The treatment of a patent foramen ovale is determined by the symptoms in each individual patient. If a patient has no symptoms, this patent can be left to self-heal. Otherwise, an operation to close the foramen ovale usually improves the symptoms of this condition. For patients with symptoms, the optimal treatment is to correct the underlying condition. Many patients require anticoagulant medications to keep their veins from closing too soon.

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