NCT00415558

Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure

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
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Maquet Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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 inclusion/exclusion 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Microwave Ablation System

Timeline

• Start date: 2007-05-01
• First posted: 2006-12-25
• Last updated: 2009-06-09

Locations

5 sites across 1 country: United States