Atrial Fibrillation
Conditions
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.
Interventions
DEVICED700 System
Atrial Fibrillation Ablation Procedure
Sponsors
EPD Solutions, A Philips Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | 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 | 30 days | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy |
Countries
Russia
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| D700 System Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
D700 System: Atrial Fibrillation Ablation Procedure | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | D700 System | — |
|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 7.6 | — |
| Arterial Hypertension | 25 participants | — |
| Body Mass Index | 30.15 kg/m2 STANDARD_DEVIATION 5.4 | — |
| CHAD2 | 1.8 units on a scale | — |
| Diabetes Mellitus | 5 Participants | — |
| Diagnosis to ablation time | 46 months STANDARD_DEVIATION 33 | — |
| LAA morphology Cactus | 3 Participants | — |
| LAA morphology Cauliflower | 16 Participants | — |
| LAA morphology Chicken wing | 12 Participants | — |
| LAA morphology Windsock | 5 Participants | — |
| LA diameter | 5.2 cm STANDARD_DEVIATION 0.7 | — |
| Moderate Alcohol Consumption | 12 Participants | — |
| NSR during procedure | 31 Participants | — |
| NYHA functional class | 1.7 class STANDARD_DEVIATION 1.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 36 participants | — |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
| Valvular Heart Disease | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
Primary
1-month Patient Analysis
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Time frame: 30 days
Population: All patients were analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| D700 (KODEX-EPD) | 1-month Patient Analysis | No 1-month gaps | Negative ETA reading at index procedure | 0 Participants |
| D700 (KODEX-EPD) | 1-month Patient Analysis | 1-month gaps | Positive ETA reading at index procedure | 18 Participants |
| D700 (KODEX-EPD) | 1-month Patient Analysis | 1-month gaps | Negative ETA reading at index procedure | 9 Participants |
| D700 (KODEX-EPD) | 1-month Patient Analysis | No 1-month gaps | Positive ETA reading at index procedure | 9 Participants |
Primary
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
Population: Analyzed ablation pairs in all participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D700 (KODEX-EPD) | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | No 1-month gaps: Positive ETA reading at index | 231 participants |
| D700 (KODEX-EPD) | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | No 1-month gaps: Negative ETA reading at index | 1549 participants |
| D700 (KODEX-EPD) | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | Actual 1-month gaps: Positive ETA reading at index | 48 participants |
| D700 (KODEX-EPD) | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | Actual 1-month gaps: Negative ETA reading at index | 13 participants |