Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-16 @ 9:59 AM
Study NCT ID:
NCT03852420
Status:
WITHDRAWN
Last Update Posted:
2021-01-15
First Post:
2019-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor discretion
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISUALISE AF
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: