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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D700 System | Experimental | Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D700 System | Device | Atrial Fibrillation Ablation Procedure |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evgeny A Pokushalov, MD, PhD | State Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analyzed ablation pairs in all participants | Posted | Number | participants | 30 days |
|
1 month; Hospitalization periods - index procedure and restudy (after 1 month from the first procedure), until discharge;
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D700 (KODEX-EPD) | All patients in which the KODEX-EPD system was used included in the group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TIA | Nervous system disorders | Systematic Assessment | The patient has developed signs of stroke following transseptal before cardiac mapping of the left atrium was initiated. The procedure was immediately aborted. All neurological deficits have resolved within a few days while in hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen Sagy Bross | EPD Solutions | +972-50-5560073 | chensb@epd-medical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2016 | Sep 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arterial Hypertension | Number | participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Valvular Heart Disease | Moderate Mitral Regurgitation | Count of Participants | Participants |
|
| Moderate Alcohol Consumption | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| NSR during procedure | Count of Participants | Participants |
|
| NYHA functional class | NYHA Functional Classification 1-Mild-Patients with cardiac disease but without resulting in limitation of physical activity. 2-Mild-Patients with cardiac disease resulting in slight limitation of physical activity. 3-Moderate-Patients with cardiac disease resulting in marked limitation of physical activity. 4-Severe-Patients with cardiac disease resulting in the inability to carry on any physical activity without discomfort. | Mean | Standard Deviation | class |
|
| CHAD2 | The CHA₂DS₂-VASc value is clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation. Risk Factor (Letter) and Score (Number): C - Congestive heart failure (1) H - Hypertension (1) A - Age ≥75 years (2) D - Diabetes Mellitus (1) S - Prior Stroke or TIA (2) V - Vascular disease (1) A - Age 65-74 years (1) Sc - Sex category (female) (1) Maximum value is the total sum of the risks numbers, which is 10. Minimum value will be only one risk which is 1. | Mean | Full Range | units on a scale |
|
| Diagnosis to ablation time | Mean | Standard Deviation | months |
|
| LA diameter | Mean | Standard Deviation | cm |
|
| LAA morphology | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | 1-month Patient Analysis | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | All patients were analyzed | Posted | Count of Participants | Participants | 30 days |
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| 0 |
| 39 |
| 1 |
| 39 |
| 0 |
| 39 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
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