DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness (DURABLE-I)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: D700 System

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Paroxysmal atrial fibrillation (PAF)
3. Able to provide written informed consent form to participate in the study, prior to any study related procedures.
4. Able and willing to comply with the study protocol requirements.
5. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Previous AF ablation therapy.
4. Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
5. Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
6. Patient has a pacemaker.
7. Thrombi detected in the heart.
8. Life expectancy less than 12 months.
9. Known severe renal insufficiency.
10. Known allergy to Iodine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: EPD Solutions, A Philips Company

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2016
• Primary Completion (Actual): January 25, 2017
• Study Completion (Actual): November 16, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 21, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: October 27, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLN-D700-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No