Agilis RF TSP Early Feasibility Study

NCT07361445 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10601
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: 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.

  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.

  During the procedure and periprocedurally

• Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.

  The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.

  Procedure

Study Arms (1)

Transseptal Procedure

EXPERIMENTAL

Device: Transseptal procedure with Agilis RF TSP System.

Interventions

Transseptal procedure with Agilis RF TSP System. DEVICE

Radiofrequency wire will be used for the transseptal procedure.

Transseptal Procedure

Eligibility Criteria

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

You may qualify if:

• Is able and willing to provide written informed consent prior to any clinical investigation-related procedure
• Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture
• Is at least 18 years of age
• Able and willing to comply with all study requirements

You may not qualify if:

• Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor
• Pregnant or nursing
• Known presence of intracardiac thrombus
• Known existing circumferential pericardial effusion (\>2 mm)
• Previous interatrial septal patch or prosthetic atrial septal defect closure device
• Any previous thromboembolic event with in the last 6 months
• Known or suspected left atrial myxoma
• Known or suspected myocardial infarction within the last two weeks
• Unstable angina
• Recent (within the last 3 months) cerebral vascular accident (CVA)
• Patients with an active infection
• Patients who do not tolerate anticoagulation therapy
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Arrhythmia Research Group (St. Bernards)

Jonesboro, Arkansas, 72401, United States

RECRUITING

California Pacific Medical Center -Van Ness Campus

San Francisco, California, 94109, United States

RECRUITING

Central Study Contacts

Ben Gansemer, PhD

CONTACT

+1 952-715-2719; benjamin.gansemer@abbott.com

Amber Miller, PhD

CONTACT

612-413-7236; amber.miller@abbott.com

Study Design

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

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)