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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01091597
The ClinicalTrials.gov registry entry for NCT01091597 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual PV ablation is the first listed.
NCT01091597 reports 0 study locations.
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.
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