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Trial Outcomes & Findings for DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness (NCT NCT02878213)

NCT ID: NCT02878213

Last Updated: 2019-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

30 days

Results posted on

2019-11-18

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 milestones

Participant milestones
Measure
D700 (KODEX-EPD) System
Paroxysmal Atrial Fibrillation (PAF) patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). D700 (KODEX-EPD) System: Atrial Fibrillation Ablation Procedure
Overall Study
STARTED
39
Overall Study
COMPLETED
36
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
D700 (KODEX-EPD) System
Paroxysmal Atrial Fibrillation (PAF) patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). D700 (KODEX-EPD) System: Atrial Fibrillation Ablation Procedure
Overall Study
Withdrawal by Subject
2
Overall Study
Adverse Event
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
D700 System
n=36 Participants
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). D700 System: Atrial Fibrillation Ablation Procedure
CHAD2
1.8 units on a scale
n=36 Participants
Diagnosis to ablation time
46 months
STANDARD_DEVIATION 33 • n=36 Participants
LA diameter
5.2 cm
STANDARD_DEVIATION 0.7 • n=36 Participants
LAA morphology
Cauliflower
16 Participants
n=36 Participants
LAA morphology
Chicken wing
12 Participants
n=36 Participants
LAA morphology
Windsock
5 Participants
n=36 Participants
LAA morphology
Cactus
3 Participants
n=36 Participants
Age, Continuous
58.5 years
STANDARD_DEVIATION 7.6 • n=36 Participants
Sex: Female, Male
Female
20 Participants
n=36 Participants
Sex: Female, Male
Male
16 Participants
n=36 Participants
Region of Enrollment
Russia
36 participants
n=36 Participants
Arterial Hypertension
25 participants
n=36 Participants
Diabetes Mellitus
5 Participants
n=36 Participants
Valvular Heart Disease
5 Participants
n=36 Participants
Moderate Alcohol Consumption
12 Participants
n=36 Participants
Body Mass Index
30.15 kg/m2
STANDARD_DEVIATION 5.4 • n=36 Participants
NSR during procedure
31 Participants
n=36 Participants
NYHA functional class
1.7 class
STANDARD_DEVIATION 1.1 • n=36 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Analyzed ablation pairs in all participants

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.

Outcome measures

Outcome measures
Measure
D700 (KODEX-EPD)
n=36 Participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy in all patients
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
No 1-month gaps: Positive ETA reading at index
231 participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Actual 1-month gaps: Negative ETA reading at index
13 participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
No 1-month gaps: Negative ETA reading at index
1549 participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Actual 1-month gaps: Positive ETA reading at index
48 participants

PRIMARY outcome

Timeframe: 30 days

Population: All patients were analyzed

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

Outcome measures

Outcome measures
Measure
D700 (KODEX-EPD)
n=36 Participants
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy in all patients
1-month Patient Analysis
1-month gaps · Positive ETA reading at index procedure
18 Participants
1-month Patient Analysis
1-month gaps · Negative ETA reading at index procedure
9 Participants
1-month Patient Analysis
No 1-month gaps · Positive ETA reading at index procedure
9 Participants
1-month Patient Analysis
No 1-month gaps · Negative ETA reading at index procedure
0 Participants

Adverse Events

D700 (KODEX-EPD)

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
D700 (KODEX-EPD)
n=39 participants at risk
All patients in which the KODEX-EPD system was used included in the group.
Nervous system disorders
TIA
2.6%
1/39 • Number of events 1 • 1 month; Hospitalization periods - index procedure and restudy (after 1 month from the first procedure), until discharge;

Other adverse events

Adverse event data not reported

Additional Information

Chen Sagy Bross

EPD Solutions

Phone: +972-50-5560073

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place