Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00415558
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 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.
Study:
NCT00415558
Study Brief:
Protocol Section:
NCT00415558