Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation (VISUALISE AF)
|ClinicalTrials.gov Identifier: NCT03852420|
Recruitment Status : Withdrawn (Sponsor discretion)
First Posted : February 25, 2019
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: LUMINIZE RF Balloon Catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
The LUMINIZE RF Balloon Catheter is a multi-electrode, irrigated, over-the-wire balloon catheter designed to facilitate cardiac electrophysiological mapping and ablation. The catheter interfaces with the LUMINIZE Console and is designed to localize potentials and create lesions using multi-polar RF energy.
The System consists of the following devices and components:
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||January 31, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Treatment with the LUMINIZE RF Balloon Catheter
Subjects undergoing cardiac ablation procedure LUMINIZE™ RF Balloon Catheter System.
Device: LUMINIZE RF Balloon Catheter
Ablation Therapy with the LUMINIZE RF Balloon Catheter
- Safety event free rate at 12 months post procedure. [ Time Frame: 0-12 months post procedure ]Primary safety events will consist of a composite of procedure-related and/or device-related adverse events.
- Failure free rate at 12 months post procedure. [ Time Frame: 0-12 months post procedure ]
Failure defined as:
- Failure to achieve acute procedural success
- Use of amiodarone post index procedure
- Surgical treatment for AF/ AFL/ AT post index procedure
- Use of a non-study ablation catheter for any AF targets in the index procedure or repeat procedure during the blanking period
- More than one repeat procedure with the LUMINIZE RF Balloon Catheter during the blanking period
- Documented atrial fibrillation, or new onset of AFL or AT between days 91 post index procedure and 365 days post index procedure captured by one of the following methods:
- ≥ 30 seconds in duration from the study specific event monitor or Holter Monitor
- ≥ 10 seconds 12-lead Electrocardiography (ECG)
- Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 post index procedure and 365 days:
- Repeat procedure
- Cardioversion for AF/AFL/AT
- Prescribed any antiarrhythmic drug (AAD)*
- Secondary Safety Endpoint [ Time Frame: 12 months ]Serious Adverse Events (SAE) and Adverse Events (AE) related to the procedure and/or study device through 12 months post Index Procedure.
- Acute procedural success [ Time Frame: 1 day ]Rate of acute procedural success defined as the achievement of electrical isolation of all pulmonary veins (PVs) by using the LUMINIZE RF Balloon Catheter system.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852420
|Principal Investigator:||Oussama Wazni||The Cleveland Clinic|