Patent Foramen OvaleNCT05537753
Encore PFO Closure Device - The PerFOrm Trial
A study testing Encore PFO closure device and FDA-approved PFO closure device in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Encore Medical Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patent Foramen Ovale, Cryptogenic Stroke
- What is being tested?
- Encore PFO closure device and FDA-approved PFO closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Jul 2023to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Bearinger contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Medical University of South Carolina Gazes Research Institute
Charleston, South Carolina, 29425
Virginia Theodorof, theodoro@musc.edu
Kavin Panneerselvam, panneeer@musc.edu
- Recruiting
Jackson Heart Clinic
Jackson, Mississippi, 39216
Jamie Neal, 601-982-7850 ext. 541, jneal@jacksonheart.com
Sandy Puckett, 601-982-7850 ext. 543, swpuckett@jacksonheart.com
- Recruiting
Kansas University Medical Center
Kansas City, Kansas, 66160
Tilitha Shawgo, RN, 913-588-9720, tshawgo@kumc.edu
Emily Work, 913-588-2613, ework@kumc.edu
- Recruiting
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
La Jolla, California, 92037
Sharon Weaver, 858-824-8261, Weaver.Sharon@scrippshealth.org
Kirsten Wade, 858-824-8263, Wade.Kirsten@scrippshealth.org
- Recruiting
Arkansas Cardiology
Little Rock, Arkansas, 72205
Bobbi Phillips, bphillips@arcard.org
Erika Jaco, erika.jaco@baptist-health.org
- Recruiting
CHI Health
Omaha, Nebraska, 68124
Barb Lapke, 402-343-8511, barb.lapke@commonspirit.org
Mel Romsa, 402-343-8511, mel.romsa@commonspirit.org
- Recruiting
University of South Florida
Tampa, Florida, 33606
Osama Abou Saleh, MD, 813-259-8835, oabousaleh@usf.edu
Vlastibor Minarovjech, minarovjech@usf.edu
- Recruiting
Mercy One Iowa Heart Center
West Des Moines, Iowa, 50266
Jennifer Young, RN, jyoung@iowaheart.com
Emily Plock, eplock@iowaheart.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke
- Being tested
- Encore PFO closure device, FDA-approved PFO closure device
- Keywords
- PFO closure, Stroke
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore PFO closure deviceDevice
The Encore PFO closure device comprises an implant component and a single-use delivery system.
FDA-approved PFO closure deviceDevice
Chosen by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Encore PFO closure device | Experimental | Not described Receives: Device: Encore PFO closure device |
| Any FDA-approved PFO closure device chosen by the investigator | Active comparator | Not described Receives: Device: FDA-approved PFO closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
Measured: 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
Measured: 6 months
Secondary outcomes (6)
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
Measured: 6 months
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
Measured: 5 years
Occurrence of transient ischemic attacks (TIA)
Measured: 5 years
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
Measured: 5 years
Occurrence of technical success
Measured: Procedural
Occurrence of procedural success
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start12 Jul 2023
- Primary completionApr 2026 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners, Yale Cardiovascular Research Group
- Responsible party
- Sponsor
- Investigators
- Christopher D Nielsen, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537753
- Sponsor's protocol ID
- ENC-CL-5000
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pandya SS. A Phase-Gated Protocol for Managing Mid-study Principal Investigator Transitions in Multi-site Investigational Device Exemption Trials. Cureus. 2026 Aug 24;18(8):e115098. doi: 10.7759/cureus.115098. eCollection 2026 Aug.
PubMed 42781600
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
- ClinicalTrials.gov ID
- NCT05537753
- Acronym / sponsor ID
- ENC-CL-5000
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke
- Keywords
- PFO closure, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Encore Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners, Yale Cardiovascular Research Group
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encore PFO closure device | Experimental | Device: Encore PFO closure device |
| Any FDA-approved PFO closure device chosen by the investigator | Active comparator | Device: FDA-approved PFO closure device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encore PFO closure deviceThe Encore PFO closure device comprises an implant component and a single-use delivery system. | Device | Encore PFO closure device |
| FDA-approved PFO closure deviceChosen by the investigator | Device | Any FDA-approved PFO closure device chosen by the investigator |
Primary outcome
Safety: The incidence of device- or procedure-related serious adverse events (SAEs)
Time frame: 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 secondary outcomes
Complete closure
Time frame: 6 months
Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death
Time frame: 5 years
Occurrence of transient ischemic attacks (TIA)
Time frame: 5 years
Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)
Time frame: 5 years
Occurrence of technical success
Time frame: Procedural
Occurrence of procedural success
Time frame: Procedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42781600Pandya SS. A Phase-Gated Protocol for Managing Mid-study Principal Investigator Transitions in Multi-site Investigational Device Exemption Trials. Cureus. 2026 Aug 24;18(8):e115098. doi: 10.7759/cureus.115098. eCollection 2026 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Bearinger contact
Christopher D Nielsen, MD principal investigator
Medical University of South Carolina
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encore PFO closure device and FDA-approved PFO closure device in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Encore Medical Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Marino (651-797-0913, jmarino@encore-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: The incidence of device- or procedure-related serious adverse events (SAEs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05537753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.