Atrial Fibrillation New OnsetNCT01247974
Evaluation Of New Onset Postoperative Atrial Fibrillation
A study testing CorMatrix ECM for Pericardial Closure in people with Atrial Fibrillation New Onset, run by Elutia Inc. at 16 sites in United States.
Trial summary
This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- CorMatrix ECM for Pericardial Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- The subject is 18 years of age or older
- This cardiac operation is the subject's first or primary cardiac operation
- The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
- The subject must possess the ability to provide written Informed Consent
- The subject must express a willingness to fulfill all of the expected requirements of this clinical protocol
Who cannot join
- Prior history of atrial fibrillation
- Prior history of open heart surgery
- Prior history of pericarditis
- Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or sotalol) in the past six months
- The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
- Concomitant procedure planned
- In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Trinity Medical Center
Birmingham, Alabama, 35213
The Ohio State University Medical Center
Columbus, Ohio, 43210
Southeast Alabama Medical Center
Dothan, Alabama, 36301
Saint Agnes Medical Center
Fresno, California, 93720
Saint Francis Heart Center
Indianapolis, Indiana, 46237
St. Vincent's Hospital
Jacksonville, Florida, 32204
St. Luke's Hospital
Kansas City, Missouri, 64111
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Providence Hospital
Mobile, Alabama, 36608
Columbia University Medical Center
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Florida Hospital
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Swedish Medical Center
Seattle, Washington, 98122
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure
This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.
Read the detailed description
The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- CorMatrix ECM for Pericardial Closure
- Keywords
- Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorMatrix ECM for Pericardial ClosureDevice
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
| Study group | Role | What they receive |
|---|---|---|
| CorMatrix ECM for Pericardial Closure | Experimental | Pericardial closure with CorMatrix ECM Receives: Device: CorMatrix ECM for Pericardial Closure |
| Control | No intervention | No Pericardial Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:
- Death
- Myocardial Infarction (MI)
- Stroke
- Mediastinal Reoperation
- Percutaneous Coronary Intervention (PCI)
Measured: 30 days postprocedure
Primary Effectiveness Endpoint
Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.
Measured: 7 days postoperatively or hospital discharge, whichever is sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial Fibrillation New OnsetStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Gerdisch, M.D., Principal investigator, St. Francis Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247974
- Sponsor's protocol ID
- 08-PR-1006
- Status last verified
- Jul 2023
- First submitted
- 23 Nov 2010
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure
- ClinicalTrials.gov ID
- NCT01247974
- Acronym / sponsor ID
- 08-PR-1006
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.
Detailed description
The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CorMatrix ECM for Pericardial Closure | Experimental | Device: CorMatrix ECM for Pericardial ClosurePericardial closure with CorMatrix ECM |
| Control | No intervention | –No Pericardial Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is 18 years of age or older
- This cardiac operation is the subject's first or primary cardiac operation
- The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
- The subject must possess the ability to provide written Informed Consent
- The subject must express a willingness to fulfill all of the expected requirements of this clinical protocol
Key exclusion criteria (7 listed)
- Prior history of atrial fibrillation
- Prior history of open heart surgery
- Prior history of pericarditis
- Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or sotalol) in the past six months
- The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorMatrix ECM for Pericardial ClosureCircumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure | Device | CorMatrix ECM for Pericardial Closure |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days postprocedure
A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure: * Death * Myocardial Infarction (MI) * Stroke * Mediastinal Reoperation * Percutaneous Coronary Intervention (PCI)
Primary Effectiveness Endpoint
Time frame: 7 days postoperatively or hospital discharge, whichever is sooner
Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marc Gerdisch, M.D. principal investigator
St. Francis Heart Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorMatrix ECM for Pericardial Closure in people with Atrial Fibrillation New Onset, run by Elutia Inc. at 16 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 5 inclusion and 7 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Safety Endpoint (time frame: 30 days postprocedure). The study lists 2 primary outcomes in all. 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 27 Jul 2023.