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Encore PFO Closure Device - The PerFOrm Trial

NCT05537753 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Patent Foramen Ovale
  • Cryptogenic Stroke

Interventions

DEVICE

Encore PFO closure device

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

DEVICE

FDA-approved PFO closure device

Chosen by the investigator

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Encore Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher D Nielsen, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2026-04-30
Completion
2030-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05537753 on ClinicalTrials.gov