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IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation

Clinical Trial Summary

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

Clinical Trial Description

Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.). 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 PEF catheter ablation procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03700385
Study type Interventional
Source Farapulse, Inc.
Contact
Status Completed
Phase N/A
Start date January 19, 2018
Completion date January 30, 2020
View Details
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