Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
Public ClinicalTrials.gov record NCT07009678. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07009678
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 21 participants
Conditions and interventions
Interventions
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2023
- Primary completion
- May 11, 2025
- Completion
- May 11, 2025
- Last update posted
- Jun 5, 2025
2023 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. John's hospital | Maple Grove | Minnesota | 55109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07009678, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 5, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07009678 live on ClinicalTrials.gov.