Health TrialsbyHealthPanel

Encore PFO Closure Device - The PerFOrm Trial

ConditionsPatent Foramen OvaleCryptogenic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEncore Medical Inc.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Encore PFO closure device

    Device

    The Encore PFO closure device comprises an implant component and a single-use delivery system.

  • FDA-approved PFO closure device

    Device

    Chosen by the investigator

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Encore PFO closure deviceExperimental treatment 1 intervention
Group B: Any FDA-approved PFO closure device chosen by the investigatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety: The incidence of device- or procedure-related serious adverse events (SAEs)

Time frame
6 months
2

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death

Time frame
5 years
3

Occurrence of transient ischemic attacks (TIA)

Time frame
5 years
4

Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Encore Medical Inc.

Lead sponsor

Bright Research Partners

Collaborator

Yale Cardiovascular Research Group

Collaborator

Source ClinicalTrials.gov
Apply now