Pericardial Access
Conditions
Keywords
Pericardial space, pericardial access
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.
Interventions
DEVICEViaOne device
ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.
Sponsors
CardioVia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 2. 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. 3. Pre-treatment coagulation values within the following limits: * international normalized ratio 0.8 - 1.2 * partial thromboplastin time 25 - 35'' 4. 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 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of ViaOne device | through study completion, an average of 5 days | Incidence of device-related adverse events through study completion, an average of 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial Efficacy of ViaOne device | through study completion, an average of 5 days | Rate of success of pericardial space access, defined as guidewire insertion into the pericardial space. |
Countries
Israel, Poland
Outcome results
None listed