Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography

Summary

Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.

Primary Investigator Carmelo Panetta, MD University of Minnesota Physicians, St. John's Hospital 1600 St. Johns Blvd, suite 200, Maplewood, MN 55109

Study Design Prospective study of the safety and efficacy upper versus lower extremity injection agitated saline (bubble study) to identify patent foramen ovale (PFO) with echocardiography

Study Objective PFO are not identified in up to one quarter of subjects who have upper arm injection compared to femoral vein injection. We propose use of the PICC line nurses to obtain access in the greater saphenous vein in the lower leg and compare to the upper extremity injection in those subjects with concern for paradoxical embolus but previously PFO was not identified with an upper arm injection.

Study Endpoint Study the safety and efficacy of lower versus upper extremity injection agitated saline (bubble study) for identifying PFO

Subject Population Subjects with history of cryptogenic stroke or arterial embolus of unknown source with negative upper extremity injection agitate saline (bubble study) to identify a PFO.

Number of Sites Three sites to enroll subjects: St. John's/Woodwinds Hospital, University of Minnesota Medical Center and Southdale Hospital. One site to perform procedure at St John's hospital

Expected Time to Complete Enrollment 8-12 months

Schedule of Events Screening and consent of subjects who with negative bubble study for PFO to have upper and lower extremity bubble study, one week follow up and review echocardiography by two cardiologists.

Additional Information Data safety monitoring board will oversee the results every quarter Sample size 20 subjects were consented and enrolled is supported by this grant from GORE Medical.

Conditions

• Patent Foramen Ovale
• Cryptogenic Stroke
• Embolic Infarction

Interventions

DIAGNOSTIC_TEST

intravenous access in greater saphenous vein compared to upper extremity site.

Ultrasound access of greater saphenous vein with placement of midline 4French catheter and use of sphygmomanometer to regulate valsalva maneuver, imaging with and without valsalva and injection of agitated saline.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• W.L.Gore & Associates

  collaborator INDUSTRY

• St. John's Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2025-05-12

Completion

2025-05-12

FDA Device

Yes

Countries

• United States

Study Locations