Clinical trial NCT05006157: Pericardial Access With ViaOne Device
Official title: Safety and Efficacy of the ViaOne Device for Pericardial Access - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pericardial Access
Keywords: Pericardial space
pericardial access
Lead sponsor: CardioVia
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of ViaOne device
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Initial Efficacy of ViaOne device
timeFrame: through study completion, an average of 5 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem MC
city: Jerusalem
country: Israel
facility: Shaare Zedek MC
city: Poznan
country: Poland
facility: SzpitalKlinicznyPrzemienieniaPańskiegoUniwersytetuMedycznegoim. Karola Marcinkowskiego w Poznaniu
city: Warsaw
country: Poland
facility: MedicoverOpiekaSzpitalna, AlejaRzeczypospolitej 5, 02-972
Study officials:
affiliation: Hadassah MC, Jerusalem, Israel
name: David Luria
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derejko P, Dzwonkowska D, Wrobel K, Kusnierz J, Bardyszewski A, Menshes Z, Hazan O, Leon A, Luria D, Lakkireddy D. Safety and Efficacy of a Novel Blunt-Tip Concealed-Needle Epicardial Access Device: First-in-Human Feasibility Study. JACC Clin Electrophysiol. 2022 Jul;8(7):908-912. doi: 10.1016/j.jacep.2022.04.016. Epub 2022 Apr 30.