Atrial FibrillationNCT00562432
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
A study testing Plexisyl-AF and No Treatment in people with Atrial Fibrillation, run by LoneStar Heart, Inc. at 3 sites in Germany.
Trial summary
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Plexisyl-AF and No Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2008to Sep 2008
- Phase
- Interventional
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients must be able and willing to give written informed consent.
- The patients will be adult (age ≥ 18 years and </= 70 years) males or females who are scheduled to undergo on-pump open-chest coronary artery bypass grafting surgery of two (2) or more arteries.
- The patients should be effectively treated prior to enrollment with an appropriate medical regimen (such as aspirin, ß-blockers, nitrates, and ACE inhibitors). Changes to medications after enrollment should be avoided.
- If female, the patients must be (a) post-menopausal, (b) surgically sterile or (c) using adequate birth control and have a negative pregnancy test within 7 days prior to administration of device.
Who cannot join
- Emergent open heart surgery.
- Patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
- Patients who have undergone a previous open chest CABG procedure.
- Previous history of atrial fibrillation or flutter.
- Patient with clinical hypothyroidism or hyperthyroidism.
- Prophylactic medication for the prevention of atrial fibrillation or current use of an antiarrhythmic medication. Patients who have been receiving beta-blockers and calcium channel blockers before screening may continue taking the medication.
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- First-degree or higher degrees of atrioventricular (AV) block (PR interval >210 msec)
- An ejection fraction of less than 30%.
- Clinically active congestive heart failure.
- Serum creatinine > 2.0 mg/dL or currently receiving dialysis.
- Clinically significant liver enzyme abnormalities (i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal).
- The patients will not be receiving concurrently an investigational product in another clinical trial or have received an investigational product in another clinical trial in the 30 days prior to enrollment.
- Any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Heart Center Dresden
Dresden
Herzzentrum Leipzig GmbH
Leipzig
Deutsches Herzzentrum München
Munich
About this study
Official title: A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF Administered to the Epicardial Fat Pads in Patients Undergoing Open-chest Coronary Artery Bypass Grafting (CABG)
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting. Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce the occurrence of postoperative atrial fibrillation and assess the performance of the electrostimulator device to confirm the location of the epicardial fat pads (nerves). The occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac monitoring.
Read the detailed description
The purpose of this study is to investigate a non-surgical and non-destructive approach to providing a temporary, protective parasympathectomy as a means to reducing postoperative atrial fibrillation following cardiac surgery. Applications of Plexisyl-AF will be placed in the cardiac fat pads as a means for creating a "non-destructive" cardiac denervation.
This is a randomized assessment to demonstrate the safety of Plexisyl-AF in patients undergoing open heart surgery. Eligible patients will be those submitted to undergo open-chest CABG. Patients will receive Plexisyl-AF, administered via direct application to the SA nodal and AV nodal epicardial fat pads during the surgical procedure.
Patients will be monitored for the occurrence of atrial fibrillation via the use of continuous cardiac monitoring for a period of 120 hours following surgery. Patients will return the clinic for brief follow-up, including electrocardiographic recordings, 10 days, 30 days and 90 days after the date of surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- Plexisyl-AF, No Treatment
- Keywords
- atrial fibrillation, CABG, ganglionated plexi
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plexisyl-AFDevice
Also called Standard surgery without device
Plexisyl-AF implants
No TreatmentOther
Also called surgery without device
CABG without the experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| Plexisyl-AF | Experimental | Plexisyl-AF implants Receives: Device: Plexisyl-AF |
| No Treatment | Sham comparator | Surgery without experimental treatment Receives: Device: Plexisyl-AF; Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Plexisyl-AF administered by direct injection to the epicardial fat pads, evaluated through analysis of freedom from adverse experiences, clinical laboratory tests, electrocardiogram and physical examinations.
Measured: 90 days
Secondary outcomes (1)
freedom from atrial fibrillation
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LoneStar Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Bauernschmitt, MD, Principal investigator, Munich Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562432
- Sponsor's protocol ID
- SYM-07-001
- Other IDs
- EudraCT Number 2007-006728-37
- Status last verified
- Sep 2008
- First submitted
- 20 Nov 2007
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF Administered to the Epicardial Fat Pads in Patients Undergoing Open-chest Coronary Artery Bypass Grafting (CABG)
- ClinicalTrials.gov ID
- NCT00562432
- Acronym / sponsor ID
- SYM-07-001
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, CABG, ganglionated plexi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LoneStar Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Nov 2007 (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 primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting. Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce the occurrence of postoperative atrial fibrillation and assess the performance of the electrostimulator device to confirm the location of the epicardial fat pads (nerves). The occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac monitoring.
Detailed description
The purpose of this study is to investigate a non-surgical and non-destructive approach to providing a temporary, protective parasympathectomy as a means to reducing postoperative atrial fibrillation following cardiac surgery. Applications of Plexisyl-AF will be placed in the cardiac fat pads as a means for creating a "non-destructive" cardiac denervation.
This is a randomized assessment to demonstrate the safety of Plexisyl-AF in patients undergoing open heart surgery. Eligible patients will be those submitted to undergo open-chest CABG. Patients will receive Plexisyl-AF, administered via direct application to the SA nodal and AV nodal epicardial fat pads during the surgical procedure.
Patients will be monitored for the occurrence of atrial fibrillation via the use of continuous cardiac monitoring for a period of 120 hours following surgery. Patients will return the clinic for brief follow-up, including electrocardiographic recordings, 10 days, 30 days and 90 days after the date of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plexisyl-AF | Experimental | Device: Plexisyl-AFPlexisyl-AF implants |
| No Treatment | Sham comparator | Device: Plexisyl-AF, Other: No TreatmentSurgery without experimental treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients must be able and willing to give written informed consent.
- The patients will be adult (age ≥ 18 years and </= 70 years) males or females who are scheduled to undergo on-pump open-chest coronary artery bypass grafting surgery of two (2) or more arteries.
- The patients should be effectively treated prior to enrollment with an appropriate medical regimen (such as aspirin, ß-blockers, nitrates, and ACE inhibitors). Changes to medications after enrollment should be avoided.
- If female, the patients must be (a) post-menopausal, (b) surgically sterile or (c) using adequate birth control and have a negative pregnancy test within 7 days prior to administration of device.
Key exclusion criteria (13 listed)
- Emergent open heart surgery.
- Patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
- Patients who have undergone a previous open chest CABG procedure.
- Previous history of atrial fibrillation or flutter.
- Patient with clinical hypothyroidism or hyperthyroidism.
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 |
|---|---|---|
| Plexisyl-AFAlso: Standard surgery without devicePlexisyl-AF implants | Device | No Treatment, Plexisyl-AF |
| No TreatmentAlso: surgery without deviceCABG without the experimental treatment | Other | No Treatment |
Primary outcome
Safety and tolerability of Plexisyl-AF administered by direct injection to the epicardial fat pads, evaluated through analysis of freedom from adverse experiences, clinical laboratory tests, electrocardiogram and physical examinations.
Time frame: 90 days
1 secondary outcome
freedom from atrial fibrillation
Time frame: 5 days
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 Mar 2011.
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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.
Robert Bauernschmitt, MD principal investigator
Munich Heart Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plexisyl-AF and No Treatment in people with Atrial Fibrillation, run by LoneStar Heart, Inc. at 3 sites in Germany.
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 4 inclusion and 13 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 Mar 2011. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of Plexisyl-AF administered by direct injection to the epicardial fat pads, evaluated through analysis of freedom from adverse experiences, clinical laboratory tests, electrocardiogram and physical examinations. (time frame: 90 days). 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 Mar 2011.