DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

NCT02878213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-11-18

Study results available
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Summary

The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.

Conditions

Interventions

DEVICE

D700 System

Atrial Fibrillation Ablation Procedure

Sponsors & Collaborators

  • EPD Solutions, A Philips Company

    lead INDUSTRY

Principal Investigators

  • Evgeny A Pokushalov, MD, PhD · State Research Institute of Circulation Pathology

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
2016-09-23
Primary Completion
2017-01-25
Completion
2017-11-16

Countries

  • Russia

Study Locations

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Entities

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 NCT02878213 on ClinicalTrials.gov