Atrial FibrillationNCT00571597
Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation
Who may be able to join
- 18 or older
- paroxysmal, persistent, or permanent atrial fibrillation
Who cannot join
- concomitant heart surgery requiring open thoracotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Cardiology Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.
Read the detailed description
Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.
- Conditions
- Atrial Fibrillation
- Keywords
- surgery, ablation, radiofrequency, minimaze, transtelephonic monitoring
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation
Measured: six months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2012
- Study completionMay 2012
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth A Ellenbogen, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571597
- Sponsor's protocol ID
- HM10695
- Status last verified
- Apr 2014
- First submitted
- 10 Dec 2007
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Han FT, Kasirajan V, Kowalski M, Kiser R, Wolfe L, Kalahasty G, Shepard RK, Wood MA, Ellenbogen KA. Results of a minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation: single-center experience with 12-month follow-up. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):370-7. doi: 10.1161/CIRCEP.109.854828. Epub 2009 Jun 2.
PubMed 19808492Han FT, Kasirajan V, Wood MA, Ellenbogen KA. Minimally invasive surgical atrial fibrillation ablation: patient selection and results. Heart Rhythm. 2009 Dec;6(12 Suppl):S71-6. doi: 10.1016/j.hrthm.2009.07.027. Epub 2009 Oct 24.
PubMed 19864190Kasirajan 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 22541178
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00571597
- Acronym / sponsor ID
- HM10695
- Conditions
- Atrial Fibrillation
- Keywords
- surgery, ablation, radiofrequency, minimaze, transtelephonic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Dec 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 purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.
Detailed description
Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation
Key inclusion criteria (2 listed)
- 18 or older
- paroxysmal, persistent, or permanent atrial fibrillation
Key exclusion criteria (1 listed)
- concomitant heart surgery requiring open thoracotomy
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
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation
Time frame: six months and 1 year
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 14 Apr 2014.
- Background: PubMed 19808492Han FT, Kasirajan V, Kowalski M, Kiser R, Wolfe L, Kalahasty G, Shepard RK, Wood MA, Ellenbogen KA. Results of a minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation: single-center experience with 12-month follow-up. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):370-7. doi: 10.1161/CIRCEP.109.854828. Epub 2009 Jun 2.
- Background: PubMed 19864190Han FT, Kasirajan V, Wood MA, Ellenbogen KA. Minimally invasive surgical atrial fibrillation ablation: patient selection and results. Heart Rhythm. 2009 Dec;6(12 Suppl):S71-6. doi: 10.1016/j.hrthm.2009.07.027. Epub 2009 Oct 24.
- Results publication: 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.
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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.
Kenneth A 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 1 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 14 Apr 2014. 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 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?
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation (time frame: six months and 1 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 NCT00571597, 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 14 Apr 2014.