MedTrace Logo

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

NCT03700372 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-10-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

IOWA Approach Cardiac Ablation System

Epicardial ablation using the IOWA Approach Cardiac Ablation System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-04-09
Completion
2021-03-03

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700372 on ClinicalTrials.gov