MedTrace Logo

"EASE" Epicardial Access With the EpiAccess System

NCT02209064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-03-07

Study results available
· View outcomes & findings →

Summary

Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

Pericardial access

Access to the pericardium to enable further treatments.

Sponsors & Collaborators

  • EpiEP, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-03-31
Completion
2015-11-30

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209064 on ClinicalTrials.gov