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

NCT07009678 | Completed DMC FDA Device

• 1 other identifier: LOCATE Study 2023
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety and efficacy of placement of access in greater saphenous vein and performing agitated saline injection (bubble study) with echocardiography to screen for patent foramen ovale.

  Placement of midline PICC line 4French in greater saphenous vein by PICC nurses with ultrasound and 18 gauge iv in right arm

  total time for procedure is 4 hours from arrival to departure. Follow up one week later to identify complications

• Comparison of injection of agitate saline via upper versus lower extremity for detection of patent foramen ovale with echocardiography

  see published manuscript - technique noted above.

  A total time of two hours for the procedure and additional 30 minutes to call the participant one week after the procedure.

Secondary Outcomes (1)

• Injection of agitated saline via greater saphenous vein compared to upper arm injection for visualization of PFO

  Two hours to do the echocardiography and additional 30 min to call the participant one week after the procedure.

Study Arms (1)

Lower extremity used for injection of agitated saline to detect PFO

EXPERIMENTAL

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

Interventions

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

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.

Also known as: agitated saline injection (bubble study)

Lower extremity used for injection of agitated saline to detect PFO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is / has:
• Age ≥18 at the time of informed consent signature.
• Capable of complying with protocol requirements, including follow-up.
• A Consent Form signed by Subject or legal representative.
• Subjects have a history of concern for right to left shunt, such as a paradoxical embolus as source of a cryptogenic CVA requiring transthoracic echocardiography with agitated saline injection (bubble study)
• No evidence of right to left shunt on injection of upper extremity using transthoracic echocardiography within the previous 24 months
• If taking warfarin, patient is eligible if clinically able to hold warfarin for 3 days prior to procedure.

You may not qualify if:

• The subject is / has:
• Enrolled in another drug or medical device study within 30 days of study enrollment.
• Absence or size \< 2mm diameter of both greater saphenous veins
• Depth of the greater saphenous vein is \> 3cm from the skin surface
• Presence of deep vein thrombosis in either greater saphenous veins
• Platelet count less than 50,000
• International Normalized Ratio (INR) \> 3 or liver failure within the last 6 months,
• Taking oral anticoagulant (DOAC) within 24 hours
• Taking high dose anticoagulation with heparin or low molecular weight heparin within 12 hours
• Absence of adequate windows for echocardiographic imaging to detect shunt
• Subject is unable to sign consent or considered a part of a vulnerable population: children/minors or age \< 18 years, pregnant women, prisoners, terminally ill, comatose, intellectually challenged individuals who are assigned a guardian, institutionalized individuals, visual or hearing impaired without therapy to overcome the impairment, refugees.

Sponsors & Collaborators

• St. John's Hospital: lead
• University of Minnesota: collaborator
• W.L.Gore & Associates: collaborator

Study Sites (1)

St. John's hospital

Maple Grove, Minnesota, 55109, United States

Location

Related Publications (1)

• Panetta CJ, Forgosh LB, Bisinov E, Hussein H, Benditt D, Miller B, Yanavitski M, Thorsgard M, Jorgenson B, Raveendran G, Iqbal N. Lower vs upper extremity injection of agitated saline for identification of patent foramen ovale (LOCATE). J Echocardiogr. 2025 Sep;23(3):188-195. doi: 10.1007/s12574-025-00685-z. Epub 2025 Mar 22.

  PMID: 40120067 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 6, 2025
• Study Start: March 1, 2023
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

US (1)