Actively Recruiting
Encore PFO Closure Device - The PerFOrm Trial
Led by Encore Medical Inc. · Updated on 2024-09-19
500
Participants Needed
8
Research Sites
376 weeks
Total Duration
On this page
Sponsors
E
Encore Medical Inc.
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Encore PFO Closure Device - The PerFOrm Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PFO confirmed by TEE with right-to-left shunting at rest or during Valsalva
- Cryptogenic stroke within the last 270 days confirmed by MRI or CT as a new cerebral infarct
- Age between 18 and 60 years
You will not qualify if you...
- Age less than 18 years or greater than 60 years
- More than 50% stenosis of intracranial or extracranial vessels
- Presence of intracardiac thrombus or tumor
- Acute or recent myocardial infarction or unstable angina within 6 months
- Left ventricular aneurysm or akinesis
- Severe mitral or aortic valve disease
- Valve vegetation or prosthesis
- Left ventricular ejection fraction less than 35%
- Other identifiable causes of stroke such as aortic arch plaques, large artery disease, cardioembolic sources, small-vessel occlusive disease, or arterial dissection
- Hypercoagulable disorder requiring anticoagulation therapy
- Other right-to-left shunts besides PFO
- History of atrial fibrillation or flutter
- Active endocarditis or untreated infections
- Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis
- Severe liver disease or cirrhosis
- Lung disease requiring continuous home oxygen
- Uncontrolled hypertension over 160/90 mm Hg despite medication
- Uncontrolled diabetes with HbA1c over 9 within the last year
- Anatomical or physiological reasons preventing transesophageal echocardiography
- Need for treatment of other structural cardiac defects
- Concomitant cardiac anomalies requiring surgery
- Bleeding disorders
- Hypersensitivity to contrast or nickel
- Contraindication to aspirin or clopidogrel
- Inability to pass required sheaths through vessels
- Vulnerable patient status such as incarceration or cognitive impairment
- Inability or unwillingness to provide informed consent
- Inability to comply with the study protocol
- Other clinical reasons deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
La Jolla, California, United States, 92037
Actively Recruiting
3
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
4
Mercy One Iowa Heart Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
5
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Actively Recruiting
7
CHI Health
Omaha, Nebraska, United States, 68124
Actively Recruiting
8
Medical University of South Carolina Gazes Research Institute
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
J
Joseph Marino
CONTACT
H
Hannah Bearinger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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