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NCT01091597 · ClinicalTrials.gov registry record · NA
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01091597: Completed NA study, sponsored by Johns Hopkins University.
NCT01091597 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091597, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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%. 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.
Interventions
- PROCEDURE usual PV ablation
- PROCEDURE Box isolation of pulmonary veins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-02 |
| Phase | NA |
What the finished NCT01091597 record still lists
NCT01091597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which usual PV ablation is the first listed.
NCT01091597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091597 about?
NCT01091597 is a clinical study titled "Pulmonary Vein (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 ...
What is the current status of trial NCT01091597?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2007-06. Estimated completion is 2009-02.
What interventions are being tested in trial NCT01091597?
The interventions under investigation include: usual PV ablation (PROCEDURE), Box isolation of pulmonary veins (PROCEDURE).
Who is sponsoring clinical trial NCT01091597?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01091597's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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