Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Poland / NCT05006157
Active, not recruiting Not applicable

Pericardial Access With ViaOne Device

NCT05006157 · tracked via the Priya Life Science Poland tracker
Sponsor
CardioVia
Phase
Not applicable
Started
2021-07-10
Last updated
2025-01-09

Condition(s) studied

Pericardial Access

Investigational drug(s) / intervention(s)

ViaOne device

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

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05006157 on ClinicalTrials.gov ↗ ← All trials in Poland