NCT02209064

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

July 29, 2014

Results QC Date

November 16, 2015

Last Update Submit

February 8, 2016

Conditions

Arrhythmias, Cardiac

Keywords

SubxiphoidAccess

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System

    EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.

    Through discharge / approx 4 days

Secondary Outcomes (2)

  • Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System

    access through procedure completion

  • Percentage of Participants With a Pericardial Effusion of >80ml

    Access through discharge/approximately 4 days

Other Outcomes (1)

  • Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System

    Access through end of procedure

Study Arms (1)

EpiAccess

OTHER

EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.

Device: Pericardial access

Interventions

Pericardial accessDEVICE

Access to the pericardium to enable further treatments.

Also known as: EpiAccess
EpiAccess

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 years of age or older
  • Pericardial access is clinically indicated
  • Patient is willing and able to provide written informed consent

You may not qualify if:

  • Patient with history of cardiac or pericardial surgery in the past 6 months
  • Patient with history of chronic pericarditis
  • Myocardial infarction within 4 weeks prior to procedure
  • Class IV NYHA (New York Heart Association) heart failure symptoms
  • Cerebrovascular accident within previous 6 months
  • Known carotid artery stenosis greater than 80%
  • Presence of thrombus in the left atrium
  • Coagulopathy
  • Severe Hepatic Dysfunction or Enlargement
  • Life expectancy less than 6 months
  • BMI \> 40
  • Patient is enrolled in another clinical trial
  • Patient is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemocnice Na Homolka

Prague, Czechia

Location

Related Publications (1)

  • Tedrow U, Stevenson WG. Strategies for epicardial mapping and ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2009 Jun;20(6):710-3. doi: 10.1111/j.1540-8167.2008.01427.x. Epub 2009 Feb 2.

    PMID: 19207780BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pam Bunes CEO & Founder
Organization
EpiEP
pbunes@epiep.com
+1 864 423 2526

Study Officials

  • Andrea Natale, MD

    University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 5, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

March 7, 2016

Results First Posted

March 7, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)