NCT03852420

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	LUMINIZE RF Balloon Catheter	Ablation Therapy with the LUMINIZE RF Balloon Catheter

Timeline

• Start date: 2021-01-31
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-02-25
• Last updated: 2021-01-15

Regulatory

• FDA-regulated device study