Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures

Study Overview
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Brief Summary
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Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter. Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.

Detailed Description
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All procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the D700 system will be used additionally to demonstrate system safety, feasibility and usability. 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 D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.

Official Title
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EP Dynamics (EPD) Research First In Man Clinical Study

Conditions
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Atrial Flutter

Intervention / Treatment
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* Procedure: AF Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. Subject is generally in good health. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. Subject is deemed amenable to therapeutic ablation for atrial flutter. Exclusion Criteria: Any planned surgical or endovascular intervention within 30 days before or after the index procedure. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. Patient had experienced previous stroke (TIA or CVA). Patient has a pacemaker. Thrombi detected in the heart. Known marked valvar insufficiency. Life expectancy less than 12 months. Known severe renal insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AF Ablation Intervention<br>Subjects who are scheduled to undergo ablation procedure due to atrial flutter. | Procedure: AF Ablation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint - Any intra-procedural or immediate post-procedure complications. |  | Intra-procedural or immediate post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Freedom from any impact on current workflow or clinical efficacy. |  | Intra-procedural or immediate post-procedure | 
| Usability - Correct visualization of the catheter spatial location (map reference). |  | Intra-procedural or immediate post-procedure |