DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

Study Overview
=================
Brief 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.

Official Title
-----------------
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: D700 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, age ≥ 18 and ≤ 80 years. Paroxysmal atrial fibrillation (PAF) Able to provide written informed consent form to participate in the study, prior to any study related procedures. Able and willing to comply with the study protocol requirements. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. Exclusion Criteria: Any planned surgical or endovascular intervention within 30 days before or after the index procedures. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. Previous AF ablation therapy. Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality. Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances. Patient has a pacemaker. Thrombi detected in the heart. Life expectancy less than 12 months. Known severe renal insufficiency. Known allergy to Iodine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D700 System<br>Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). | Device: D700 System<br>* Atrial Fibrillation Ablation Procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings. All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month. | 30 days | 
| 1-month Patient Analysis | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | 30 days |