Actively Recruiting
Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
Led by Encore Medical Inc. · Updated on 2024-09-19
500
Participants Needed
8
Research Sites
234 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
Researchers are evaluating the safety, effectiveness, and noninferiority of the Encore PFO closure device compared to any FDA-approved PFO closure device chosen by investigators. The study focuses on patients who have had a cryptogenic stroke caused by a presumed paradoxical embolism and involves closing a patent foramen ovale (PFO) through a percutaneous, transcatheter procedure. This prospective, multicenter, randomized clinical study aims to provide reasonable assurance of the Encore device's safety and effectiveness. Participants will be randomly assigned to receive either the Encore PFO closure device, which includes an implant component and a single-use delivery system, or an FDA-approved PFO closure device selected by the investigator. The procedure involves using these devices to close the PFO via catheter-based delivery. The study design includes comparison of procedural and device-related outcomes between these two groups. During the study, participants will be monitored for safety, including the incidence of serious adverse events related to the device or procedure within 6 months. Effectiveness will be assessed by measuring the success of PFO closure at 6 months. Additional evaluations include long-term monitoring for recurrent stroke, transient ischemic attacks, new atrial arrhythmias, and procedural success over 5 years. Participants will undergo imaging, neurological assessments, and follow-up visits to track outcomes and overall safety throughout the study period.
CONDITIONS
Brief Title
Encore PFO Closure Device - The PerFOrm Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of patent foramen ovale confirmed by heart ultrasound with microbubble visualization within three cardiac cycles
- Cryptogenic stroke within the last 270 days confirmed by MRI or CT as a new cerebral infarct
- Age between 18 and 60 years
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Younger than 18 years or older than 60 years
- More than 50% narrowing of intracranial or extracranial blood vessels
- Presence of intracardiac thrombus or tumor
- Recent (within 6 months) heart attack or unstable angina
- Left ventricular aneurysm or akinesis
- Mitral valve stenosis or severe mitral regurgitation
- Aortic valve stenosis or severe aortic valve regurgitation
- Mitral or aortic valve infection or prosthetic valve
- Left ventricular ejection fraction less than 35%
- Other known causes of stroke such as aortic plaques, large artery disease, cardioembolism, or arterial dissection
- Hypercoagulable disorder requiring anticoagulation treatment
- Other right-to-left heart shunts besides PFO
- History of atrial fibrillation or atrial flutter
- Active endocarditis or untreated infections
- Severe kidney or liver disease
- Lung disease needing continuous oxygen
- Uncontrolled high blood pressure or diabetes
- Anatomical or physiological issues preventing heart ultrasound
- Need for treatment of other structural heart defects
- Coagulopathy or bleeding disorders
- Allergy to contrast medium or nickel
- Contraindication to aspirin or clopidogrel
- Inability to pass required sheaths to access the PFO
- Vulnerable patients such as incarcerated or cognitively challenged adults
- Inability or unwillingness to give informed consent or comply with the protocol
- Other clinical reasons making the patient unsuitable for the study as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedural
Participants receive a percutaneous, transcatheter closure of a patent foramen ovale (PFO) using either the Encore PFO closure device or an FDA-approved PFO closure device chosen by the investigator.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and effectiveness outcomes including closure success and occurrence of related adverse events.
Regular follow-up visits over 5 years
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
H
Hannah Bearinger
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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