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Agilis RF TSP Early Feasibility Study

Abbott Medical Devices · NCT07361445

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
3
Study start
February 16, 2026
Record last updated
June 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Transseptal procedure with Agilis RF TSP System.

Conditions: Cardiac Arrythmias; Left Atrial Appendage Closure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Ben Gansemer, PhD · +1 952-715-2719 · benjamin.gansemer@abbott.com
  • Amber Miller, PhD · 612-413-7236 · amber.miller@abbott.com
Agilis RF TSP Early Feasibility Study (NCT07361445) | Bored Studies