Arrhythmias, Cardiac
Conditions
Keywords
Subxiphoid, Access
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.
Detailed description
Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained. As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study. The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.
Interventions
DEVICEPericardial access
Access to the pericardium to enable further treatments.
Sponsors
EpiEP, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 18 years of age or older 2. Pericardial access is clinically indicated 3. Patient is willing and able to provide written informed consent
Exclusion criteria
1. Patient with history of cardiac or pericardial surgery in the past 6 months 2. Patient with history of chronic pericarditis 3. Myocardial infarction within 4 weeks prior to procedure 4. Class IV NYHA (New York Heart Association) heart failure symptoms 5. Cerebrovascular accident within previous 6 months 6. Known carotid artery stenosis greater than 80% 7. Presence of thrombus in the left atrium 8. Coagulopathy 9. Severe Hepatic Dysfunction or Enlargement 10. Life expectancy less than 6 months 11. BMI \> 40 12. Patient is enrolled in another clinical trial 13. Patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System | Through discharge / approx 4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System | 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. |
| Percentage of Participants With a Pericardial Effusion of >80ml | Access through discharge/approximately 4 days | Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System | 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 |
Countries
Czechia
Participant flow
Recruitment details
25 Patients were enrolled at five sites in Europe between February 7th 2014 and March 16, 2015
Participants by arm
| Arm | Count |
|---|---|
| EpiAccess 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | EpiAccess |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 61.9 years |
| Region of Enrollment Czech Republic | 10 participants |
| Region of Enrollment France | 2 participants |
| Region of Enrollment Italy | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EpiAccess | Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System | 100 percentage of patients |
Secondary
Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
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.
Time frame: access through procedure completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EpiAccess | Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System | 100 percentage of patients |
Secondary
Percentage of Participants With a Pericardial Effusion of >80ml
Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.
Time frame: Access through discharge/approximately 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EpiAccess | Percentage of Participants With a Pericardial Effusion of >80ml | 0 percentage of participants |
Other Pre-specified
Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
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
Time frame: Access through end of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EpiAccess | Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System | 24 participants |