Agilis RF system to cross the atrial septum for left heart access

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, acute, first-in-human early feasibility study testing the Agilis RF Transseptal System to cross the atrial septum for left atrial and left ventricular access during electrophysiology and interventional cardiology procedures. The device is used during transseptal puncture in procedures such as left atrial or ventricular ablation and left atrial appendage occlusion device implantation. Subjects are treated in an acute hospital setting and monitored through hospital discharge with no scheduled post-discharge study visits. The study will record immediate procedural success and acute safety outcomes related to crossing the septum.

Why it matters

Who can join: the full rules

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

Where it's running

• Arrhythmia Research Group (St. Bernards)
  Jonesboro, Arkansas, United States Recruiting
• California Pacific Medical Center -Van Ness Campus
  San Francisco, California, United States Recruiting
• Research Medical Center
  Kansas City, Missouri, United States Recruiting

Study contacts

• Study coordinator: Ben Gansemer, PhD
• Email: benjamin.gansemer@abbott.com
• Phone: +1 952-715-2719

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure in AF Patients

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• Intracardiac versus transesophageal guidance for left atrial appendage closure

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• Registry documenting left atrial appendage closure procedures in Austria

  This study is collecting information on patients with atrial fibrillation in Austria who have had a left atrial appendage closure procedure because they can't take blood thinners, to see how safe and effective the treatment is.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.