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RECRUITING NA

Agilis RF TSP Early Feasibility Study

NCT07361445 · View on ClinicalTrials.gov ↗

Study Summary

This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.

Interventions

  • DEVICE Transseptal procedure with Agilis RF TSP System.

Study Locations (2)

Arkansas

  • Arrhythmia Research Group (St. Bernards) — Jonesboro

California

  • California Pacific Medical Center -Van Ness Campus — San Francisco

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-02-16
Est. Completion 2026-08-03
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07361445

The ClinicalTrials.gov registry entry for NCT07361445 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Left Atrial Appendage Closure appearing as the primary indexed condition, and to 1 intervention — of which Transseptal procedure with Agilis RF TSP System. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07361445 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07361445 about?

NCT07361445 is a clinical study titled "Agilis RF TSP Early Feasibility Study". This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP...

What is the current status of trial NCT07361445?

This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-02-16. Estimated completion is 2026-08-03.

What conditions does trial NCT07361445 study?

This clinical trial studies the following conditions: Left Atrial Appendage Closure, Cardiac Arrythmias. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07361445?

The interventions under investigation include: Transseptal procedure with Agilis RF TSP System. (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07361445?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07361445 being conducted?

This trial has 2 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial