Pulsed Field Ablation (PFA)
DevicePFA using Irreversible Electroporation (IRE) Ablation System
NCT Number: NCT06099730
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
St. Bernard's Heart and Vascular Center, Jonesboro, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PFA using Irreversible Electroporation (IRE) Ablation System
Time frame: within seven (7) days of an ablation procedure
Time frame: effectiveness evaluation period (Day 91-Day 365)
Time frame: during ablation procedure
Massachusetts General Hospital
Other
Acronym: POLARIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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