NCT02878213

DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: EPD Solutions, A Philips Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, single-center, non-randomized, non-blinded, open label, and single arm study. All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented. The entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	D700 System	Atrial Fibrillation Ablation Procedure

Timeline

• Start date: 2016-09-23
• Primary completion: 2017-01-25
• Completion: 2017-11-16
• First posted: 2016-08-25
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

1 site across 1 country: Russia