Pericardial Access With ViaOne Device

Study Overview
=================
Brief Summary
-----------------
ViaOne device is a tool designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac. In this study ViaOne will be used to obtain pericardial access in patients in whom electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended pericardial space is indicated.

Detailed Description
-----------------
The primary objective of the study is to provide evidence of safety of ViaOne in obtaining percutaneous subxiphoid approach to the pericardial space. The secondary objective is to provide initial estimate of efficacy of ViaOne in obtaining percutaneous subxiphoid approach to the pericardial space. Screening procedures will include laboratory analyses of the complete blood count, serum chemistry, coagulation parameters, and urine or serum ß-HCG test.A physical examination and collection of vital signs will be conducted. Medical history data and information on concomitant medications will be collected. Once eligibility is verified, subjects will be scheduled for a procedure during which percutaneous subxiphoid pericardial access will be obtained using the ViaOne and its associated procedure. Time period between the study device insertion through the subxiphoid incision and guidewire insertion into the pericardial sac, overall time in procedure, and any procedural complications and device deficiencies will be recorded. Follow-up visit will be conducted as part of the planned protocol procedures at up 5 ± 1 days after the procedure or at the time of discharge, whichever comes first. The visit will include evaluation of any adverse events and complications. Length of hospital stay will be recorded, where the discharge precedes or coincides with the final follow-up visit of the study.

Official Title
-----------------
Safety and Efficacy of the ViaOne Device for Pericardial Access - a Feasibility Study

Conditions
-----------------
Pericardial Access

Intervention / Treatment
-----------------
* Device: ViaOne device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 21 Electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended ericardial space is indicated. Pre-treatment coagulation values within the following limits: international normalized ratio 0.8 - 1.2 partial thromboplastin time 25 - 35'' Pre-treatment hematology and biochemistry values within the following limits: hemoglobin ≥ 10 g/dL (g/100 mL) platelets ≥ 150 x 10^9/L (x 10^3/mm^3) white blood cells ≥ 3.0 x 10^9/L (x 10^3/mm^3) absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1.5 x 10^3/mm^3) serum creatinine < 1.5 mg/dL aspartate aminotransferase < 1.5 x ULN (upper limit of norm) alanine aminotransferase < 1.5 x ULN alkaline phosphatase < 1.5 x ULN Signed informed consent. Exclusion Criteria: History of cardiac or pericardial surgery or prior pericardial ablation. History of chronic pericarditis. Known pericardial fibrosis and/or adhesions. Any anomaly in the chest anatomy. Myocardial infarction, past or present. Bleeding disorders. Hepatic enlargement. BMI > 40 Participation in another interventional trial. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ViaOne device<br>ViaOne device will be used for percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac | Device: ViaOne device<br>* ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of ViaOne device | Incidence of device-related adverse events through study completion, an average of 5 days | through study completion, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial Efficacy of ViaOne device | Rate of success of pericardial space access, defined as guidewire insertion into the pericardial space. | through study completion, an average of 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pericardial space, pericardial access