Back to resultsDURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness (DURABLE-I)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
D700 System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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.
Sites / Locations
- Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D700 System
Arm Description
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
Outcomes
Primary Outcome Measures
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.
1-month Patient Analysis
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Secondary Outcome Measures
Full Information
NCT ID
NCT02878213
First Posted
July 28, 2016
Last Updated
October 27, 2019
Sponsor
EPD Solutions, A Philips Company
1. Study Identification
Unique Protocol Identification Number
NCT02878213
Brief Title
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Acronym
DURABLE-I
Official Title
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 23, 2016 (Actual)
Primary Completion Date
January 25, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EPD Solutions, A Philips Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D700 System
Arm Type
Experimental
Arm Description
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
Intervention Type
Device
Intervention Name(s)
D700 System
Intervention Description
Atrial Fibrillation Ablation Procedure
Primary Outcome Measure Information:
Title
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Description
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.
Time Frame
30 days
Title
1-month Patient Analysis
Description
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
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