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IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System — IMPACT  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

Clinical Trial Summary

IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

Clinical Trial Description

Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.), followed by concomitant cardiac surgery. Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the index ablation procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03700372
Study type Interventional
Source Farapulse, Inc.
Contact
Status Completed
Phase
Start date December 13, 2017
Completion date March 3, 2021
View Details
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