Atrial FibrillationSTARNCT00747838
A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias
An observational study of Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Minimally Invasive Maze Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2012
- 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: Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.
Who may be able to join
- Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
- > 18 years of age
Who cannot join
- Patients unable to give adequate informed consent
- Patients who are known to be pregnant, plan to become pregnant or are lactating
- Inability to return for follow up
- Patients who are prison inmates or institutionalized
- Patients in an emergency state
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Minimally Invasive Maze Procedure
- Keywords
- Afib, Atrial Fibrillation, Maze, Mini-Maze
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Maze ProcedureProcedure or surgery
Minimally Invasive Surgical Correction of Atrial Fibrillation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionDec 2012
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vigneshwar Kasirajan, MD, Principal investigator, Virginia Commonwealth UniversityKenneth Ellenbogen, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747838
- Sponsor's protocol ID
- STAR Outcomes
- Acronym
- STAR
- Status last verified
- May 2013
- First submitted
- 4 Sep 2008
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Saini A, Hu YL, Kasirajan V, Han FT, Khan MZ, Wolfe L, Gunda S, Koneru JN, Ellenbogen KA. Long-term outcomes of minimally invasive surgical ablation for atrial fibrillation: A single-center experience. Heart Rhythm. 2017 Sep;14(9):1281-1288. doi: 10.1016/j.hrthm.2017.04.029. Epub 2017 Apr 22.
PubMed 28438723Kasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
PubMed 22541178Kron J, Kasirajan V, Wood MA, Kowalski M, Han FT, Ellenbogen KA. Management of recurrent atrial arrhythmias after minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation. Heart Rhythm. 2010 Apr;7(4):445-51. doi: 10.1016/j.hrthm.2009.12.008. Epub 2009 Dec 16.
PubMed 20156608
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)
- ClinicalTrials.gov ID
- NCT00747838
- Acronym / sponsor ID
- STAR / STAR Outcomes
- Conditions
- Atrial Fibrillation
- Keywords
- Afib, Atrial Fibrillation, Maze, Mini-Maze
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Sep 2008 (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.
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.
Key inclusion criteria (2 listed)
- Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
- > 18 years of age
Key exclusion criteria (6 listed)
- Patients unable to give adequate informed consent
- Patients who are known to be pregnant, plan to become pregnant or are lactating
- Inability to return for follow up
- Patients who are prison inmates or institutionalized
- Patients in an emergency state
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 |
|---|---|---|
| Minimally Invasive Maze ProcedureMinimally Invasive Surgical Correction of Atrial Fibrillation. | Procedure or surgery | – |
Primary outcome
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation
Time frame: One Year
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Derived from this study: PubMed 28438723Saini A, Hu YL, Kasirajan V, Han FT, Khan MZ, Wolfe L, Gunda S, Koneru JN, Ellenbogen KA. Long-term outcomes of minimally invasive surgical ablation for atrial fibrillation: A single-center experience. Heart Rhythm. 2017 Sep;14(9):1281-1288. doi: 10.1016/j.hrthm.2017.04.029. Epub 2017 Apr 22.
- Derived from this study: PubMed 22541178Kasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
- Derived from this study: PubMed 20156608Kron J, Kasirajan V, Wood MA, Kowalski M, Han FT, Ellenbogen KA. Management of recurrent atrial arrhythmias after minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation. Heart Rhythm. 2010 Apr;7(4):445-51. doi: 10.1016/j.hrthm.2009.12.008. Epub 2009 Dec 16.
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Atrial Fibrillation (AF)
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.
Vigneshwar Kasirajan, MD principal investigator
Virginia Commonwealth University
Kenneth Ellenbogen, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Virginia Commonwealth University at 1 site 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Low enrollment.). Results are not available in the source record.
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?
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747838, which also lists 3 linked publications.
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 May 2013.