EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry (EASYER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02481102|
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : February 1, 2018
|Condition or disease|
The Registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the United States. The overall duration of the registry is estimated to be 18 months per site. For the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days.
Prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be considered enrolled in the registry after written informed consent is obtained.
As EpiAccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. Follow up clinical examinations will be performed according to institutional standard of care. No special tests are required for this device.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||4 Days|
|Official Title:||EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||November 28, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- Number of Participants with Adverse Events as Measure of Safety [ Time Frame: Up to 4 days post procedure (or until time of discharge) ]Number of Participants with Adverse Events as Measure of Safety
- Health Economics [ Time Frame: Up to 4 days post procedure (or until time of discharge) ]Number of Participants with Extended Hospital Stay as a Measure of Health Economic Value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481102
|Contact: Claire Williamsfirstname.lastname@example.org|
|Contact: Pam Bunesemail@example.com|
|United States, Texas|
|Texas Cardiac Arrhythmia||Recruiting|
|Austin, Texas, United States, 78705|
|Contact: Andrea Natale, MD 512-458-9410 firstname.lastname@example.org|
|Contact: Deb Cardinal 512-458-9410 email@example.com|
|Principal Investigator:||Andrea Natale, MD||Texas Cardiac Arrhythmia Research Foundation|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine, Mount Sinai Hospital|