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CompletedNCT02878213DURABLE-IUpdated Nov 18, 2019Results posted

DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

An interventional study of D700 System in Atrial Fibrillation, sponsored by EPD Solutions, A Philips Company. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by EPD Solutions, A Philips Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 39 is below the median of 144 across 2,381 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

EPD Solutions, A Philips Company is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    D700 System

    Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).

    Device: D700 System

Interventions

  • DeviceD700 System

    Atrial Fibrillation Ablation Procedure

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 1-month Patient Analysis

    ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy

    Time frame: 30 days

07

Results

Posted Nov 18, 2019

Participant flow

For DURABLE-1 22 consecutive paroxysmal atrial fibrillation patients were recruited. The trial was extended (DURABLE-1.1) and altogether 39 paroxysmal atrial fibrillation patients were recruited.

Participant flow — Overall Study
MilestoneD700 (KODEX-EPD) System
Started39
Completed36
Not completed3
Withdrew: Withdrawal by subject2
Withdrew: Adverse event1

Outcome measures

PrimaryETA 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.

Time frame:
30 days
Reported as:
Number · participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
participantsD700 (KODEX-EPD)
No 1-month gaps: Positive ETA reading at index231
No 1-month gaps: Negative ETA reading at index1549
Actual 1-month gaps: Positive ETA reading at index48
Actual 1-month gaps: Negative ETA reading at index13
Primary1-month Patient Analysis

ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy

Time frame:
30 days
Reported as:
Count of participants · Participants
1-month Patient Analysis
ParticipantsD700 (KODEX-EPD)
1-month gaps — Positive ETA reading at index procedure18
1-month gaps — Negative ETA reading at index procedure9
No 1-month gaps — Positive ETA reading at index procedure9
No 1-month gaps — Negative ETA reading at index procedure0

Adverse events

Collected over 1 month; Hospitalization periods - index procedure and restudy (after 1 month from the first procedure), until discharge;. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
D700 (KODEX-EPD)0/39 (0%)1/39 (2.6%)0/39 (0%)
Most frequent serious events
Most frequent serious events
EventD700 (KODEX-EPD)
TIANervous system disorders1/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)D700 System
Mean58.5 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)D700 System
Female20
Male16
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)D700 System
Region of Enrollment
Region of Enrollment(participants)D700 System
Russia36
Arterial Hypertension
Arterial Hypertension(participants)D700 System
Number25
Diabetes Mellitus
Diabetes Mellitus(Participants)D700 System
Count of participants5
Valvular Heart Disease
Valvular Heart Disease(Participants)D700 System
Count of participants5
Moderate Alcohol Consumption
Moderate Alcohol Consumption(Participants)D700 System
Count of participants12

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
    Novosibirsk, 630055, Russian Federation
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 18, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02878213
Lead sponsor
EPD Solutions, A Philips Company
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Sep 23, 2016
Primary completion
Jan 25, 2017
Completion
Nov 16, 2017
Results posted
Nov 18, 2019
Last update
Nov 18, 2019

Study contacts

Evgeny A Pokushalov, MD, PhD
principal investigator · State Research Institute of Circulation Pathology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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