Pericardial Access With ViaOne Device

NCT ID: NCT05006157

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-10
• Study Completion Date: 2025-06-30

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.

Conditions

Pericardial Access

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ViaOne device

ViaOne device will be used for percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac

Group Type: EXPERIMENTAL

ViaOne device

Intervention Type: DEVICE

ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.

Interventions

ViaOne device

ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Luria

Role: PRINCIPAL_INVESTIGATOR

Hadassah MC, Jerusalem, Israel

Locations

Hadassah Ein Kerem MC

Jerusalem, , Israel

Shaare Zedek MC

Jerusalem, , Israel

SzpitalKlinicznyPrzemienieniaPańskiegoUniwersytetuMedycznegoim. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

MedicoverOpiekaSzpitalna, AlejaRzeczypospolitej 5, 02-972

Warsaw, , Poland

Countries

Israel; Poland

References

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.

Reference Type: DERIVED

PMID: 35750622 (View on PubMed)

Other Identifiers

CAV-CL-011

Identifier Type: -

Identifier Source: org_study_id