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New treatment option for PFO
Official title Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study
ClinicalTrials.gov ID: NCT07698951
What this study is testing
- What it's testing
- The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is: Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patient must be ≥ 18 and ≤ 65 years of age
- Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification...
- Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a...
- Modified Rankin score (mRS) ≤ 3.
- Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.
You likely can't join if
- Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery...
- Other arteriopathy of the intracranial or extracranial vessels with \>50% stenosis proximal to the territory of the index stroke.
- Intracardiac thrombus or tumor.
- Myocardial Infarction (MI) or unstable angina within the previous 180 days.
- Life expectancy \< 2 years.
- Left ventricular aneurysm or akinesis.
See the full eligibility criteria
Who can join
- Patient must be ≥ 18 and ≤ 65 years of age
- Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva...
- Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.
- Modified Rankin score (mRS) ≤ 3.
- Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.
- Patient is willing and capable of providing informed consent.
- Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.
What rules you out
- Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an...
- Other arteriopathy of the intracranial or extracranial vessels with \>50% stenosis proximal to the territory of the index stroke.
- Intracardiac thrombus or tumor.
- Myocardial Infarction (MI) or unstable angina within the previous 180 days.
- Life expectancy \< 2 years.
- Left ventricular aneurysm or akinesis.
- Moderate to severe mitral valve stenosis or severe mitral regurgitation.
- Aortic valve stenosis (mean gradient \>20 mmHg) or severe regurgitation.
- Active endocarditis or other infection that may preclude implantation of the investigational device.
- Any valve vegetation or Lambl's excrescence of any left-sided valve.
- Left ventricular dilated cardiomyopathy with LVEF \<35%.
- Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation.
- History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.
- Severe renal failure ( Stage 4 CKD, eGFR \<30) or patient requiring dialysis.
- Severe liver disease (e.g., documented cirrhosis or active hepatitis).
- Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
- Uncontrolled hypertension, defined as sustained elevated blood pressure \>140/90 mm Hg.
- Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \>50mmHg.
- Uncontrolled hyperglycemia, defined as HbA1c value \>8% (IFCC: \>64 mmol/mol).
- Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding...
- Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
- people contraindicated for aspirin or clopidogrel.
- people not able to discontinue anticoagulation for indications other than then index stroke.
- Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent...
- Currently an active subject in an investigational drug or device study that could confound the results of this study.
- Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
- Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
- Any prior percutaneous cardiovascular intervention for AF ablation.
- Known nickel allergy that, in the opinion of the investigator, poses a safety risk with regards to participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Belgrade, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belgrade, Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.