Atrial FibrillationNCT00587899
Prophylactic Pulmonary Vein Isolation Study
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history 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?
- Pulmonary Vein Isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium
Who cannot join
- History of Atrial Fibrillation
- Need for emergent cardiac surgery
- Previous cardiac surgery
- Preoperative need for an intraaortic balloon pump or intravenous inotropes
- Current diagnosis of active endocarditis
- Mental impairment/or experience other conditions which may not allow subject to understand nature
- Significance and scope of study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery
This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.
Read the detailed description
Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.
Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.
Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).
Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary Vein Isolation
- Keywords
- Atrial Fibrillation, AF, A fib, cardiac ablation, modified maze procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein IsolationProcedure or surgery
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation. Receives: Procedure: Pulmonary Vein Isolation |
| 2 | No intervention | The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.
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.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Thoralf M. Sundt, III, M.D., Principal investigator, Professor of Surgery, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587899
- Sponsor's protocol ID
- 06-005543
- Status last verified
- Apr 2011
- First submitted
- 22 Dec 2007
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT00587899
- Acronym / sponsor ID
- 06-005543
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, AF, A fib, cardiac ablation, modified maze procedure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Jan 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.
This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.
Detailed description
Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.
Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.
Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).
Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Pulmonary Vein IsolationThe treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation. |
| 2 | No intervention | –The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium
Key exclusion criteria (8 listed)
- History of Atrial Fibrillation
- Need for emergent cardiac surgery
- Previous cardiac surgery
- Preoperative need for an intraaortic balloon pump or intravenous inotropes
- Current diagnosis of active endocarditis
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 |
|---|---|---|
| Pulmonary Vein IsolationThe treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF. | Procedure or surgery | 1 |
Primary outcome
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Thoralf M. Sundt, III, M.D. principal investigator
Professor of Surgery, Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation, run by Mayo Clinic 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 1 inclusion and 8 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 14 Apr 2011. 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: enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.). 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?
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording. (time frame: 12 months). 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 14 Apr 2011.