DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness (DURABLE-I)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness|
- Gap detection [ Time Frame: 30 days ]Evaluation of ablation gap detection using EPD D700 system.
|Study Start Date:||September 2016|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: D700 System
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
Device: D700 System
Atrial Fibrillation Ablation Procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02878213
|Contact: Marina M Nikitenkofirstname.lastname@example.org|
|Contact: Andrei Bazarov, MD||+7 495 956 1309 ext email@example.com|
|Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology||Recruiting|
|Novosibirsk, Russia, Russian Federation, 630055|
|Contact: Alexander Romanov +73833327655|
|Principal Investigator:||Evgeny A Pokushalov, MD, PhD||State Research Institute of Circulation Pathology|