Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392106
Status:
SUSPENDED
Last Update Posted:
2008-06-17
First Post:
2006-10-24
Brief Title:
High Intensity Focused Ultrasound HIFU Ablation System Study
Sponsor:
ProRhythm Inc
Organization:
ProRhythm Inc
Study Overview
Official Title:
Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
Status:
SUSPENDED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
voluntarily by Sponsor to investigate an anticipated SAE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs
Detailed Description:
Atrial fibrillation AF is the most common sustained cardiac arrhythmia affecting an estimated 22 million persons in the United States US In addition to being debilitating AF has been identified as a leading risk factor for stroke AF is often associated with structural heart disease but a substantial number of AF patients have little or no detectable structural heart disease A patient with AF is up to 5 times more likely to have a stroke than the general population
Recently it has been demonstrated that for a significant portion of AF patients 80 - 95 the arrhythmia originates in one of the four pulmonary veins PVs Furthermore it has been shown that isolation of this arrhythmia by ablation can in the majority of patients 50-70 eliminate or markedly reduce episodes of AF Currently there are a number of modalities being investigated to treat AF They include radiofrequency laser thermal cryo microwave and ultrasound ablation of targeted areas in the atrium andor PVs
Comparisons Clinical success of High Intensity Focused Ultrasound HIFU Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation compared to medical therapy with anti-arrhythmic drugs AADs
Recently it has been demonstrated that for a significant portion of AF patients 80 - 95 the arrhythmia originates in one of the four pulmonary veins PVs Furthermore it has been shown that isolation of this arrhythmia by ablation can in the majority of patients 50-70 eliminate or markedly reduce episodes of AF Currently there are a number of modalities being investigated to treat AF They include radiofrequency laser thermal cryo microwave and ultrasound ablation of targeted areas in the atrium andor PVs
Comparisons Clinical success of High Intensity Focused Ultrasound HIFU Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation compared to medical therapy with anti-arrhythmic drugs AADs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCT00392106 | None | None | None |