RECRUITING

Encore PFO Closure Device - The PerFOrm Trial

Conditions

Patent Foramen Ovale Cryptogenic Stroke PFO closure Stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Official Title

Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial

Quick Facts

Study Start:2023-07-12

Study Completion:2030-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05537753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 release 2. 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	1. Age \<18 years and age \>60 years 2. Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels 3. Intracardiac thrombus or tumor 4. Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina 5. Left ventricular aneurysm or akinesis 6. Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation 7. Aortic valve stenosis (gradient \>40 mmHg) or severe aortic valve regurgitation 8. Mitral or aortic valve vegetation or prosthesis 9. Left ventricular ejection fraction \<35% 10. Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection 11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine 12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum 13. Any history of atrial fibrillation/atrial flutter (chronic or intermittent) 14. Active endocarditis or other untreated infections 15. Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30) 16. Severe liver disease (ALT 3X ULN) or documented cirrhosis 17. Lung disease requiring continuous home oxygen 18. Uncontrolled hypertension, defined as sustained elevated blood pressure \>160/90 mm Hg on medication 19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year) 20. Anatomical or physiological structures that do not permit TEE 21. Anticipated need for treatment of structural cardiac defects other than PFO 22. Concomitant cardiac anomalies requiring an operative procedure 23. Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis) 24. Hypersensitivity to contrast medium or nickel 25. Contraindication to aspirin or clopidogrel 26. The required sheaths cannot be passed through the relevant vessels for access to the PFO 27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1 28. Subject is unable or unwilling to provide informed consent 29. Subject is unable to comply with the protocol 30. Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators

Inclusion Criteria

Exclusion Criteria

1. 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 release
2. 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

1. Age \<18 years and age \>60 years
2. Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
3. Intracardiac thrombus or tumor
4. Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
5. Left ventricular aneurysm or akinesis
6. Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
7. Aortic valve stenosis (gradient \>40 mmHg) or severe aortic valve regurgitation
8. Mitral or aortic valve vegetation or prosthesis
9. Left ventricular ejection fraction \<35%
10. Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine
12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
13. Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
14. Active endocarditis or other untreated infections
15. Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
16. Severe liver disease (ALT 3X ULN) or documented cirrhosis
17. Lung disease requiring continuous home oxygen
18. Uncontrolled hypertension, defined as sustained elevated blood pressure \>160/90 mm Hg on medication
19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
20. Anatomical or physiological structures that do not permit TEE
21. Anticipated need for treatment of structural cardiac defects other than PFO
22. Concomitant cardiac anomalies requiring an operative procedure
23. Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
24. Hypersensitivity to contrast medium or nickel
25. Contraindication to aspirin or clopidogrel
26. The required sheaths cannot be passed through the relevant vessels for access to the PFO
27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
28. Subject is unable or unwilling to provide informed consent
29. Subject is unable to comply with the protocol
30. Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators

Contacts and Locations

Study Contact

Joseph Marino

CONTACT

651-797-0913

jmarino@encore-medical.com

Hannah Bearinger

CONTACT

hannah.bearinger@brightresearch.com

Principal Investigator

Christopher D Nielsen, MD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Arkansas Cardiology

Little Rock, Arkansas, 72205

United States

Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital

La Jolla, California, 92037

United States

University of South Florida

Tampa, Florida, 33606

United States

Mercy One Iowa Heart Center

West Des Moines, Iowa, 50266

United States

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

Jackson Heart Clinic

Jackson, Mississippi, 39216

United States

CHI Health

Omaha, Nebraska, 68124

United States

Medical University of South Carolina Gazes Research Institute

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Encore Medical Inc.

Christopher D Nielsen, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-12

Study Completion Date2030-10

Study Record Updates

Study Start Date2023-07-12

Study Completion Date2030-10

Terms related to this study

Keywords Provided by Researchers

PFO closure
Stroke

Additional Relevant MeSH Terms

Patent Foramen Ovale
Cryptogenic Stroke