DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
D700 System
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
Intervention: D700 System (Device)
Outcomes
Primary Outcomes
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Time Frame: 30 days
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.
1-month Patient Analysis
Time Frame: 30 days
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Secondary Outcomes
No secondary outcomes reported