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NCT07361445 · ClinicalTrials.gov registry record · NA
Agilis RF TSP Early Feasibility Study
A NA study of Left Atrial Appendage Closure and Cardiac Arrythmias, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT07361445: Recruiting NA study of Left Atrial Appendage Closure and Cardiac Arrythmias, sponsored by Abbott Medical Devices.
NCT07361445 is a NA study of Left Atrial Appendage Closure and Cardiac Arrythmias that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07361445, a NA study of Left Atrial Appendage Closure and Cardiac Arrythmias, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-02-16 |
| Est. Completion | 2026-08-03 |
| Phase | NA |
What NCT07361445 shows while recruiting
NCT07361445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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.
NCT07361445 reports a single indexed study location in Arkansas, California.
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.
What interventions are being tested in trial NCT07361445?
The interventions under investigation include: Transseptal procedure with Agilis RF TSP System. (DEVICE).
Who is sponsoring clinical trial NCT07361445?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07361445's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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