Agilis RF TSP Early Feasibility Study
NCT07361445 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-11
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.
Conditions
- Cardiac Arrythmias
- Left Atrial Appendage Closure
Interventions
- DEVICE
-
Transseptal procedure with Agilis RF TSP System.
Radiofrequency wire will be used for the transseptal procedure.
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-16
- Primary Completion
- 2026-06-01
- Completion
- 2026-08-03
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03681496 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07219446 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07303764 ·Status: WITHHELD
-
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
NCT07363473 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07339046 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06138665 ·Status: WITHHELD
-
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
NCT04799145 ·Status: COMPLETED
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07348796 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07349745 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00739245 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01738165 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01443286 ·Status: WITHHELD
-
PRAME Immunohistochemistry-Guided Slow Mohs Micrographic Surgery for the Treatment of Stage 0 to IIc Cutaneous Melanoma
NCT07258446 ·Status: SUSPENDED ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00732134 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01476826 ·Status: WITHHELD
-
EVERO Drug-coated Balloon (DCB) Randomized Trial
NCT07144150 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07063459 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01700764 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02134236 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00769340 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07014995 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00732264 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02141334 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01463618 ·Status: WITHHELD
-
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
NCT07112365 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4