Recruiting

Agilis™ RF TSP

Sponsor:

Abbott Medical Devices

Code:

NCT07361445

Conditions

Cardiac Arrythmias

Left Atrial Appendage Closure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transseptal procedure with Agilis RF TSP System.

Study Details

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

Study ID

NCT07361445

Start date

Feb 16, 2026

Status verified date

May, 2026

Completion date

Aug 3, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Transseptal Procedure

Interventions

Transseptal procedure with Agilis RF TSP System.

Radiofrequency wire will be used for the transseptal procedure.

Primary outcome measure

  • 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. [ Time Frame: During the procedure and periprocedurally ]
  • Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician. [ Time Frame: Procedure ]

Central Contacts and Locations

Central contacts

Ben Gansemer, PhD

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

Amber Miller, PhD

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

Locations

Arrhythmia Research Group (St. Bernards)

Recruiting

Jonesboro, Arkansas, United States, 72401

California Pacific Medical Center -Van Ness Campus

Recruiting

San Francisco, California, United States, 94109

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64132

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-06-02.