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PFO Closure Device
Encore PFO Closure Device for Patent Foramen Ovale
N/A
Recruiting
Led By Christopher D Nielsen, MD
Research Sponsored by Encore Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of a new PFO closure device to existing ones.
Who is the study for?
Adults aged 18-60 with a recent cryptogenic stroke and diagnosed Patent Foramen Ovale (PFO) can join. They must have had a stroke within the last 270 days confirmed by MRI or CT, without other known causes of stroke, no severe heart issues, uncontrolled blood pressure or diabetes, clotting disorders, nickel allergy, or severe kidney/liver disease.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of the Encore PFO closure device compared to any FDA-approved PFO closure device for preventing strokes in people with PFO. Participants will be randomly assigned to receive either the Encore device or another approved device.See study design
What are the potential side effects?
Potential side effects may include discomfort at the insertion site, allergic reactions to materials like nickel or contrast used during procedures, irregular heartbeat risks associated with heart devices, and less commonly complications such as blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke with unknown cause in the last 270 days, confirmed by MRI or CT.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness: Effective closure
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
Secondary outcome measures
Complete closure
Atrial Fibrillation
Occurrence of procedural success
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Encore PFO closure deviceExperimental Treatment1 Intervention
Group II: Any FDA-approved PFO closure device chosen by the investigatorActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Encore Medical Inc.Lead Sponsor
Bright Research PartnersIndustry Sponsor
13 Previous Clinical Trials
1,254 Total Patients Enrolled
Yale Cardiovascular Research GroupOTHER
7 Previous Clinical Trials
2,426 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood clot or tumor in my heart.My kidney function is very low or I am on dialysis.My heart has a weakened or bulging area.I cannot or do not want to give permission for treatment.You have a different type of heart condition that allows blood to flow abnormally between the right and left sides of the heart.I have not had a heart attack or unstable chest pain in the last 6 months.I had a stroke with unknown cause in the last 270 days, confirmed by MRI or CT.You have more than 50% blockage in the blood vessels in or around your brain.I have severe liver disease or cirrhosis.Your heart is not pumping enough blood.I am either younger than 18 or older than 60.You are allergic to contrast dye or nickel.My stroke has a known cause like heart issues or specific artery conditions.I need blood thinners due to a clotting disorder confirmed by specific blood tests.My most recent HbA1c level was 9 or higher.Your blood pressure is consistently high, even with medication.I do not have any bleeding disorders.You have a heart condition where there is a hole between the left and right atrium that causes blood to flow in the wrong direction.My heart's mitral valve is narrow or leaks severely.I cannot take aspirin or clopidogrel due to health reasons.You have problems with your heart valves or have had valve replacement surgery.I need to use oxygen at home all the time.I cannot undergo TEE due to my body's structure.I expect to need treatment for a heart defect other than a hole between heart chambers.I need surgery for a heart condition.I have severe narrowing or leaking of the aortic valve in my heart.I have a history of atrial fibrillation or flutter.I do not have any untreated infections or active endocarditis.The necessary tools cannot be used to reach the PFO through the blood vessels.
Research Study Groups:
This trial has the following groups:- Group 1: Any FDA-approved PFO closure device chosen by the investigator
- Group 2: Encore PFO closure device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial accessible to individuals aged 25 or older?
"The inclusion criteria for this study states that patients must be between 18 and 60 years of age. There are 7 trials available to under-18s, while 370 studies are tailored towards those aged over 65."
Answered by AI
Are there any current openings for participants in this trial?
"Affirmative. Data hosted on clinicaltrials.gov shows that this trial, initially posted on the first of March 2023, is still actively recruiting patients to participate. The study needs 500 people from one location to join in their research efforts."
Answered by AI
How many individuals are participating in this research?
"Affirmative, the clinicaltrials.gov database alludes to this medical trial's active recruitment period. It was initially published on March 1st 2023 with a subsequent edit made on March 23rd 2023. 500 individuals are being sought from one particular site."
Answered by AI
Could I qualify to volunteer for this research project?
"This medical study is currently enrolling 500 patients, aged between 18 and 60, who have been diagnosed with patent foramen ovale. Applicants must also meet the following eligibility criteria: visible microbubbles within three cardiac cycles of right atrial opacification when resting or during Valsalva release; cryptogenic stroke within 270 days prior to application; MRI or CT confirmation of a neuroanatomically relevant cerebral infarct occurring in association with the stroke."
Answered by AI
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