Encore PFO Closure Device - The PerFOrm Trial

January 3, 2024 updated by: Encore Medical Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Cavendish, MD
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bibhu Mohanty, MD
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Kansas University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georges Hajj, MD
        • Sub-Investigator:
          • Eric Hockstad, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Jackson Heart Clinic
        • Principal Investigator:
          • William Crowder, MD
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68124
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina Gazes Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher D Nielsen, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Encore PFO closure device
Device: Encore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
Active Comparator: Any FDA-approved PFO closure device chosen by the investigator
Device: FDA-approved PFO closure device
Chosen by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
Time Frame: 6 months
6 months
Effectiveness: Effective closure
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete closure
Time Frame: 6 months
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
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
Time Frame: 5 years
5 years
Occurrence of transient ischemic attacks (TIA)
Time Frame: 5 years
5 years
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
Time Frame: 5 years
5 years
Occurrence of technical success
Time Frame: Procedural
Procedural
Occurrence of procedural success
Time Frame: Procedural
Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encore Medical Inc.

Collaborators

Bright Research Partners
Yale Cardiovascular Research Group

Investigators

  • Principal Investigator: Christopher D Nielsen, MD, 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 Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENC-CL-5000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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