Atrial FibrillationNCT01091597
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
A study testing usual PV ablation and Box isolation of pulmonary veins in people with Atrial Fibrillation and Radiofrequency Ablation, run by Johns Hopkins University at 1 site in United States.
Trial summary
Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Radiofrequency Ablation
- What is being tested?
- usual PV ablation and Box isolation of pulmonary veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.
Who cannot join
- Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation
- Being tested
- usual PV ablation, Box isolation of pulmonary veins
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual PV ablationProcedure or surgery
usual PV ablation, per above
Box isolation of pulmonary veinsProcedure or surgery
as above
| Study group | Role | What they receive |
|---|---|---|
| usual ablation | Active comparator | Wide-area circumferential ablation of the pulmonary veins Receives: Procedure: usual PV ablation |
| Box isolation of the pulmonary veins | Experimental | Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium. Receives: Procedure: Box isolation of pulmonary veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from atrial fibrillation
Measured: 3 months following ablation
Secondary outcomes (1)
safety of Box isolation
Measured: 3 months following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Johns Hopkins 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091597
- Sponsor's protocol ID
- NA_00008424
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chilukuri K, Scherr D, Dalal D, Cheng A, Spragg D, Nazarian S, Barcelon BD, Marine JE, Calkins H, Henrikson CA. Conventional pulmonary vein isolation compared with the "box isolation" method: a randomized clinical trial. J Interv Card Electrophysiol. 2011 Nov;32(2):137-46. doi: 10.1007/s10840-011-9587-8. Epub 2011 May 26.
PubMed 21614530
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01091597
- Acronym / sponsor ID
- NA_00008424
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Mar 2010 (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.
Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual ablation | Active comparator | Procedure: usual PV ablationWide-area circumferential ablation of the pulmonary veins |
| Box isolation of the pulmonary veins | Experimental | Procedure: Box isolation of pulmonary veinsSingle Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.
Key exclusion criteria (1 listed)
- Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation
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 |
|---|---|---|
| usual PV ablationusual PV ablation, per above | Procedure or surgery | usual ablation |
| Box isolation of pulmonary veinsas above | Procedure or surgery | Box isolation of the pulmonary veins |
Primary outcome
freedom from atrial fibrillation
Time frame: 3 months following ablation
1 secondary outcome
safety of Box isolation
Time frame: 3 months following procedure
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 24 Mar 2010.
- Derived from this study: PubMed 21614530Chilukuri K, Scherr D, Dalal D, Cheng A, Spragg D, Nazarian S, Barcelon BD, Marine JE, Calkins H, Henrikson CA. Conventional pulmonary vein isolation compared with the "box isolation" method: a randomized clinical trial. J Interv Card Electrophysiol. 2011 Nov;32(2):137-46. doi: 10.1007/s10840-011-9587-8. Epub 2011 May 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usual PV ablation and Box isolation of pulmonary veins in people with Atrial Fibrillation and Radiofrequency Ablation, run by Johns Hopkins 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 1 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 24 Mar 2010. 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?
freedom from atrial fibrillation (time frame: 3 months following ablation). 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 NCT01091597, which also lists 1 linked publication.
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 24 Mar 2010.