Agilis RF TSP Early Feasibility Study
Recruiting
N/A
Interventional Study
Cardiac Arrythmias
Left Atrial Appendage Closure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 60 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
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. S…
Trial Locations
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Eligibility 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 …
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