Encore PFO Closure Device - The PerFOrm Trial
Primary Purpose
Patent Foramen Ovale, Cryptogenic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Encore PFO closure device
FDA-approved PFO closure device
Sponsored by
About this trial
This is an interventional treatment trial for Patent Foramen Ovale focused on measuring PFO closure, Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
- 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:
- Age <18 years and age >60 years
- Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
- Intracardiac thrombus or tumor
- Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
- Left ventricular aneurysm or akinesis
- Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
- Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation
- Mitral or aortic valve vegetation or prosthesis
- Left ventricular ejection fraction <35%
- 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
- 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
- Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
- Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
- Active endocarditis or other untreated infections
- Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
- Severe liver disease (ALT 3X ULN) or documented cirrhosis
- Lung disease requiring continuous home oxygen
- Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mm Hg on medication
- Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
- Anatomical or physiological structures that do not permit TEE
- Anticipated need for treatment of structural cardiac defects other than PFO
- Concomitant cardiac anomalies requiring an operative procedure
- Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
- Hypersensitivity to contrast medium or nickel
- Contraindication to aspirin or clopidogrel
- The required sheaths cannot be passed through the relevant vessels for access to the PFO
- Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
- Subject is unable or unwilling to provide informed consent
- Subject is unable to comply with the protocol
- Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators
Sites / Locations
- Arkansas CardiologyRecruiting
- Mercy One Iowa Heart CenterRecruiting
- Kansas University Medical CenterRecruiting
- Jackson Heart ClinicRecruiting
- CHI HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Encore PFO closure device
Any FDA-approved PFO closure device chosen by the investigator
Arm Description
Outcomes
Primary Outcome Measures
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
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
Secondary Outcome Measures
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
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
Occurrence of transient ischemic attacks (TIA)
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
Occurrence of technical success
Occurrence of procedural success
Full Information
NCT ID
NCT05537753
First Posted
September 8, 2022
Last Updated
September 11, 2023
Sponsor
Encore Medical Inc.
Collaborators
Bright Research Partners, Yale Cardiovascular Research Group
1. Study Identification
Unique Protocol Identification Number
NCT05537753
Brief Title
Encore PFO Closure Device - The PerFOrm Trial
Official Title
Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Medical Inc.
Collaborators
Bright Research Partners, Yale Cardiovascular Research Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale, Cryptogenic Stroke
Keywords
PFO closure, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Encore PFO closure device
Arm Type
Experimental
Arm Title
Any FDA-approved PFO closure device chosen by the investigator
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Encore PFO closure device
Intervention Description
The Encore PFO closure device comprises an implant component and a single-use delivery system.
Intervention Type
Device
Intervention Name(s)
FDA-approved PFO closure device
Intervention Description
Chosen by the investigator
Primary Outcome Measure Information:
Title
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
Time Frame
6 months
Title
Effectiveness: Effective closure
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete closure
Description
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
Time Frame
6 months
Title
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
Time Frame
5 years
Title
Occurrence of transient ischemic attacks (TIA)
Time Frame
5 years
Title
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
Time Frame
5 years
Title
Occurrence of technical success
Time Frame
Procedural
Title
Occurrence of procedural success
Time Frame
Procedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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:
Age <18 years and age >60 years
Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
Intracardiac thrombus or tumor
Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
Left ventricular aneurysm or akinesis
Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation
Mitral or aortic valve vegetation or prosthesis
Left ventricular ejection fraction <35%
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
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
Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
Active endocarditis or other untreated infections
Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
Severe liver disease (ALT 3X ULN) or documented cirrhosis
Lung disease requiring continuous home oxygen
Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mm Hg on medication
Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
Anatomical or physiological structures that do not permit TEE
Anticipated need for treatment of structural cardiac defects other than PFO
Concomitant cardiac anomalies requiring an operative procedure
Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
Hypersensitivity to contrast medium or nickel
Contraindication to aspirin or clopidogrel
The required sheaths cannot be passed through the relevant vessels for access to the PFO
Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
Subject is unable or unwilling to provide informed consent
Subject is unable to comply with the protocol
Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Corcoran
Phone
651-797-0913
Email
mcorcoran@encore-medical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Bearinger
Email
hannah@brightresearchpartners.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Nielsen, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Cardiology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobbi Phillips
Email
bphillips@arcard.org
First Name & Middle Initial & Last Name & Degree
Erika Jaco
Email
erika.jaco@baptist-health.org
First Name & Middle Initial & Last Name & Degree
Ernesto Ruiz-Rodriguez, MD
First Name & Middle Initial & Last Name & Degree
Thomas Evans Watts, MD
Facility Name
Mercy One Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Young, RN
Email
jyoung@iowaheart.com
First Name & Middle Initial & Last Name & Degree
Emily Plock
Email
eplock@iowaheart.com
First Name & Middle Initial & Last Name & Degree
Mark Tannenbaum, MD
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tilitha Shawgo, RN
Phone
913-588-9720
Email
tshawgo@kumc.edu
First Name & Middle Initial & Last Name & Degree
Emily Work
Phone
913-588-2613
Email
ework@kumc.edu
First Name & Middle Initial & Last Name & Degree
Georges Hajj, MD
First Name & Middle Initial & Last Name & Degree
Eric Hockstad, MD
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Neal
Phone
601-982-7850
Ext
541
Email
jneal@jacksonheart.com
First Name & Middle Initial & Last Name & Degree
Sandy Puckett
Phone
601-982-7850
Ext
543
Email
swpuckett@jacksonheart.com
First Name & Middle Initial & Last Name & Degree
William Crowder, MD
Facility Name
CHI Health
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barb Lapke
Phone
402-343-8511
Email
barb.lapke@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Mel Romsa
Phone
402-343-8511
Email
mel.romsa@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Himanshu Agarwal, MD
12. IPD Sharing Statement
Learn more about this trial
Encore PFO Closure Device - The PerFOrm Trial
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