Arrhythmias, CardiacEASYERNCT02481102
EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry
An observational study of Arrhythmias, Cardiac, run by EpiEP, Inc. at 3 sites in United States.
Trial summary
The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2015to 9 Feb 2021
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.
Who may be able to join
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Who cannot join
- Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes:
- Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis
- Congenital absence of a pericardium
- Absence of a free epicardial space
- Patients with active infection
- History of chronic pericarditis
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- Patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- Patient not in normal sinus rhythm
- Presence of thrombus in the left atrium
- Coagulopathy
- Known allergy to contrast media
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Vivek Reddy
New York, New York, NY 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, PA19104
About this study
Official title: EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry
The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.
Read the detailed description
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.
- Conditions
- Arrhythmias, Cardiac
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as Measure of Safety
Number of Participants with Adverse Events as Measure of Safety
Measured: Up to 4 days post procedure (or until time of discharge)
Secondary outcomes (1)
Health Economics
Number of Participants with Extended Hospital Stay as a Measure of Health Economic Value
Measured: Up to 4 days post procedure (or until time of discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start30 Jun 2015
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- EpiEP, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research FoundationVivek Reddy, MD, Principal investigator, Icahn School of Medicine, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481102
- Sponsor's protocol ID
- QT-0020
- Acronym
- EASYER
- Status last verified
- Feb 2021
- First submitted
- 18 Jun 2015
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry
- ClinicalTrials.gov ID
- NCT02481102
- Acronym / sponsor ID
- EASYER / QT-0020
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- EpiEP, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Key exclusion criteria (11 listed)
- Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes:
- Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis
- Congenital absence of a pericardium
- Absence of a free epicardial space
- Patients with active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Health Economics
Time frame: Up to 4 days post procedure (or until time of discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
Vivek Reddy, MD principal investigator
Icahn School of Medicine, Mount Sinai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by EpiEP, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as Measure of Safety (time frame: Up to 4 days post procedure (or until time of discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.