Agilis Radiofrequency Transseptal System Early Feasibility Study
Abbott Medical Devices
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Sp…
Interventions
- DeviceTransseptal procedure with Agilis RF TSP System.
Radiofrequency wire will be used for the transseptal procedure.
Locations (2)
- Arrhythmia Research Group (St. Bernards)Jonesboro, Arkansas
- California Pacific Medical Center -Van Ness CampusSan Francisco, California