NCT03700385

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	IOWA Approach Endocardial Ablation System	Endocardial ablation using the IOWA Approach Endocardial Ablation System

Timeline

• Start date: 2018-01-19
• Primary completion: 2018-12-21
• Completion: 2020-01-30
• First posted: 2018-10-09
• Last updated: 2020-09-23
• Results posted: 2020-09-23

Locations

2 sites across 2 countries: Czechia, France

Regulatory

• FDA-regulated device study