Pericardial Access With ViaOne Device

August 30, 2023 updated by: CardioVia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Ein Kerem MC
        • Contact:
        • Principal Investigator:
          • Ayelet Shauer, MD
      • Jerusalem, Israel
  • Poland
      • Poznan, Poland
        • Recruiting
        • SzpitalKlinicznyPrzemienieniaPańskiegoUniwersytetuMedycznegoim. Karola Marcinkowskiego w Poznaniu
        • Contact:
          • Krzysztof Błaszyk, MD
        • Contact:
        • Principal Investigator:
          • Krzysztof Błaszyk, MD
      • Warsaw, Poland
        • Recruiting
        • MedicoverOpiekaSzpitalna, AlejaRzeczypospolitej 5, 02-972
        • Contact:
          • Pawel Derejko, MD
        • Contact:
        • Principal Investigator:
          • Pawel Derejko, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioVia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 25, 2024

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAV-CL-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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