Trial Outcomes & Findings for "EASE" Epicardial Access With the EpiAccess System (NCT NCT02209064)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Through discharge / approx 4 days

Results posted on

2016-03-07

Participant Flow

25 Patients were enrolled at five sites in Europe between February 7th 2014 and March 16, 2015

Participant milestones

Participant milestones
Measure	EpiAccess EpiAccess was 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. Pericardial access: Access to the pericardium to enable further treatments.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

"EASE" Epicardial Access With the EpiAccess System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EpiAccess n=25 Participants 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. Pericardial access: Access to the pericardium to enable further treatments.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants
Age, Continuous	61.9 years n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	19 Participants n=99 Participants
Region of Enrollment Czech Republic	10 participants n=99 Participants
Region of Enrollment Italy	13 participants n=99 Participants
Region of Enrollment France	2 participants n=99 Participants

PRIMARY outcome

Timeframe: Through discharge / approx 4 days

Population: Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.

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.

Outcome measures

Outcome measures
Measure	EpiAccess n=25 Participants 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. Pericardial access: Access to the pericardium to enable further treatments.
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System	100 percentage of patients

SECONDARY outcome

Timeframe: access through procedure completion

EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.

Outcome measures

Outcome measures
Measure	EpiAccess n=25 Participants 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. Pericardial access: Access to the pericardium to enable further treatments.
Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System	100 percentage of patients

SECONDARY outcome

Timeframe: Access through discharge/approximately 4 days

Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.

Outcome measures

Outcome measures
Measure	EpiAccess n=25 Participants 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. Pericardial access: Access to the pericardium to enable further treatments.
Percentage of Participants With a Pericardial Effusion of >80ml	0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Access through end of procedure

Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey

Outcome measures

Outcome measures
Measure	EpiAccess n=25 Participants 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. Pericardial access: Access to the pericardium to enable further treatments.
Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System	24 participants

Adverse Events

EpiAccess

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EpiAccess n=25 participants at risk EpiAccess was 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. Pericardial access: Access to the pericardium to enable further treatments.
Cardiac disorders Unintended right ventricular puncture	4.0% 1/25 • Number of events 1
Cardiac disorders Pericardial Effusion	4.0% 1/25 • Number of events 1
Cardiac disorders Acute ischemia of left superficial femoral artery	4.0% 1/25 • Number of events 1

Additional Information

Pam Bunes CEO & Founder

EpiEP

Phone: +1 864 423 2526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place