NCT03700372

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	IOWA Approach Cardiac Ablation System	Epicardial ablation using the IOWA Approach Cardiac Ablation System

Timeline

• Start date: 2017-12-13
• Primary completion: 2019-04-09
• Completion: 2021-03-03
• First posted: 2018-10-09
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

1 site across 1 country: France