Pericardial Access With ViaOne Device

• Sponsor: CardioVia (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05006157
• Collaborator: (none)
• Enrollment: 10
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 14.5
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pericardial Access	Device: ViaOne device	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of the ViaOne Device for Pericardial Access - a Feasibility Study
• Actual Study Start Date: Jul 10, 2021
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Sep 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ViaOne device ViaOne device will be used for percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac	Device: ViaOne device; ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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''

1. 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

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Ein Kerem MC	Jerusalem		Israel
2	Shaare Zedek MC	Jerusalem		Israel
3	SzpitalKlinicznyPrzemienieniaPańskiegoUniwersytetuMedycznegoim. Karola Marcinkowskiego w Poznaniu	Poznan		Poland
4	MedicoverOpiekaSzpitalna, AlejaRzeczypospolitej 5, 02-972	Warsaw		Poland

Sponsors and Collaborators

• CardioVia

Investigators

• Principal Investigator: David Luria, Hadassah MC, Jerusalem, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CardioVia
• ClinicalTrials.gov Identifier: NCT05006157
• Other Study ID Numbers: CAV-CL-011
• First Posted: Aug 16, 2021
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CardioVia: Pericardial space; pericardial access

Study Results

No Results Posted as of Mar 4, 2022