Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation
NCT03852420 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2021-01-15
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).
Conditions
- Paroxysmal Atrial Fibrillation
Interventions
- DEVICE
-
LUMINIZE RF Balloon Catheter
Ablation Therapy with the LUMINIZE RF Balloon Catheter
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Oussama Wazni · The Cleveland Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-31
- Primary Completion
- 2021-12-31
- Completion
- 2022-12-31
- FDA Device
- Yes
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