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Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation — VISUALISE AF  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Safety and Effectiveness Evaluation of Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation

Clinical Trial Summary

To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).

Clinical Trial Description

The VISUALISE AF study is a multi-center (global), open label, prospective, single arm study to establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System. The planned indication for use within the United States for LUMINIZE RF Balloon Catheter System is for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03852420
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Withdrawn
Phase N/A
Start date January 31, 2021
Completion date December 31, 2022
View Details
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