NCT03232645

Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation

ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Ablation procedure	Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter

Timeline

• Start date: 2018-01-08
• Primary completion: 2020-06-23
• Completion: 2020-08-05
• First posted: 2017-07-28
• Last updated: 2021-09-05
• Results posted: 2021-08-09

Locations

6 sites across 4 countries: France, Germany, Spain, United Kingdom