Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415558
Status:
TERMINATED
Last Update Posted:
2009-06-09
First Post:
2006-12-20
Brief Title:
Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
Sponsor:
Maquet Cardiovascular
Organization:
Maquet Cardiovascular
Study Overview
Official Title:
Prospective Multicenter Un-Blinded Single Arm Clinical Study Using the Guidant Microwave Ablation System Comprised of the Flex 10 Ablation Probe and Microwave Generator for Patients With Symptomatic Paroxysmal Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
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 prospective single-arm un-blinded multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation PAF in the minimally invasive surgical MIS procedure in approximately 30 patients at 6 investigational sites in the United States
Detailed Description:
The study population for this study will be comprised of patients who have been diagnosed with symptomatic PAF for at least 6 months prior to study entry Patients will be qualified for the study if they meet stringent inclusionexclusion criteria signing an informed consent and agreeing to return for followup visits at 1 3 6 9 and 12 months All study patients will receive microwave ablation to treat their symptomatic PAF The Microwave Ablation System will be used during a MIS procedure on a beating heart in order to ablate a specified lesion pattern
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