Encore PFO Closure Device - The PerFOrm Trial

Patent Foramen Ovale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537753
• Other study ID #: ENC-CL-5000
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: October 2029

Study information

• Verified date: January 2024
• Source: Encore Medical Inc.
• Contact: Mike Corcoran
• Phone: 651-797-0913
• Email: mcorcoran[@]encore-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2029
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Ischemic Stroke
• Patent Foramen Ovale

Intervention

Device:
• Encore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
• FDA-approved PFO closure device
Chosen by the investigator

Locations

Country	Name	City	State
United States	Medical University of South Carolina Gazes Research Institute	Charleston	South Carolina
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital	La Jolla	California
United States	Arkansas Cardiology	Little Rock	Arkansas
United States	CHI Health	Omaha	Nebraska
United States	University of South Florida	Tampa	Florida
United States	Mercy One Iowa Heart Center	West Des Moines	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Encore Medical Inc.	Bright Research Partners, Yale Cardiovascular Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: The incidence of device- or procedure-related serious adverse events (SAEs)		6 months
Primary	Effectiveness: Effective closure	Defined as shunt grade 0 or I while at rest and during Valsalva as assessed by transesophageal echocardiography (TEE) and bubble study as adjudicated by the echocardiographic core laboratory	6 months
Secondary	Complete closure	Defined as shunt grade 0 while at rest and during Valsalva as assessed by TEE and bubble study as adjudicated by the echocardiographic core laboratory	6 months
Secondary	Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death		5 years
Secondary	Occurrence of transient ischemic attacks (TIA)		5 years
Secondary	Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)		5 years
Secondary	Occurrence of technical success		Procedural
Secondary	Occurrence of procedural success		Procedural