Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardial access | Device | Access to the pericardium to enable further treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | access through procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Access through end of procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolka | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19207780 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
25 Patients were enrolled at five sites in Europe between February 7th 2014 and March 16, 2015
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of patients | Through discharge / approx 4 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unintended right ventricular puncture | Cardiac disorders | Systematic Assessment | Right ventricular puncture without pericardial effusion due to patient anatomy and not related to use of the EpiAccess System |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pam Bunes CEO & Founder | EpiEP | +1 864 423 2526 | pbunes@epiep.com |
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of Participants With a Pericardial Effusion of >80ml |
Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml. |
| Access through discharge/approximately 4 days |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Number | percentage of patients | access through procedure completion |
|
|
|
| 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. | Posted | Number | percentage of participants | Access through discharge/approximately 4 days |
|
|
|
| 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 | Posted | Number | participants | Access through end of procedure |
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment | Pericardial effusion requiring treatment not associated with use of the EpiAccess System |
|
| Acute ischemia of left superficial femoral artery | Cardiac disorders | Systematic Assessment | Not device or access related |
|
Not provided
Not provided