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

NCT03232645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-09-05

Study results available
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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

DEVICE

Ablation procedure

Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ignacio Garcia Bolao, MD · Clinica Universitaria de Navarra

  • Bruno Reissmann, MD · Universitäres Herzzentrum Hamburg

  • Armin Luik, MD · Stadtisches Klinikum Karlsruhe

  • Pierre Jais, MD · University Hospital, Bordeaux

  • Moloy Das, MD · Freeman Health System

  • Waqas Ullah, MD · University Hospital Southampton NHS Foundation Trust

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
2018-01-08
Primary Completion
2020-06-23
Completion
2020-08-05

Countries

  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03232645 on ClinicalTrials.gov