Encore PFO Closure Device - The PerFOrm Trial
Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
1 other identifier
interventional
500
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
ExpectedSeptember 19, 2024
September 1, 2024
2.7 years
September 8, 2022
September 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
6 months
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 Outcomes (6)
Complete closure
6 months
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
5 years
Occurrence of transient ischemic attacks (TIA)
5 years
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
5 years
Occurrence of technical success
Procedural
- +1 more secondary outcomes
Study Arms (2)
Encore PFO closure device
EXPERIMENTALAny FDA-approved PFO closure device chosen by the investigator
ACTIVE COMPARATORInterventions
The Encore PFO closure device comprises an implant component and a single-use delivery system.
Chosen by the investigator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Encore Medical Inc.lead
- Bright Research Partnerscollaborator
- Yale Cardiovascular Research Groupcollaborator
Study Sites (8)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Nielsen, MD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 13, 2022
Study Start
July 12, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2030
Last Updated
September 19, 2024
Record last verified: 2024-09