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Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
This study has been terminated.
( Low enrollment )
Study NCT00415558   Information provided by Maquet Cardiovascular
First Received: December 20, 2006   Last Updated: June 5, 2009   History of Changes

December 20, 2006
June 5, 2009
May 2007
 
 
 
Complete list of historical versions of study NCT00415558 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

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.

 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Atrial Fibrillation
Device: Microwave Ablation System
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
 
 
 

Inclusion Criteria:

  • Patient is greater than or = 18 years of age
  • Patient has documented symptomatic paroxysmal atrial fibrillation (PAF) refractory to at least 1 antiarrhythmic (Class IA, IC, III) drug.
  • Patient has episodes of symptomatic AF including, but not limited to, palpitations, lightheadedness, fatigue, dyspnea, and/or chest pain.
  • A minimum of a 6-month history of symptomatic paroxysmal AF (documented by patient report in the medical record).
  • A minimum of 2 discrete symptomatic paroxysmal AF episodes in the month prior to study entry. Paroxysmal AF rhythm must be documented by objective evidence (12-lead electrocardiogram [ECG], Holter monitor, event monitor, or other telemetry rhythm strip) with the presence of sinus rhythm and/or underlying rhythm between episodes.
  • Patient has been informed of the nature of the study, agreed to its provisions, and provided written informed consent.

Exclusion Criteria:

  • Patient had a cerebral vascular accident or transient ischemic attack within the previous 6 months.
  • Patient had a myocardial infarction within the previous 6 weeks.
  • Patient has underlying metabolic etiology related to AF (e.g., hyperthyroidism, metabolic disorder).
  • Patient has significant underlying structural heart disease (e.g., valvular disease, presence of aneurysm, left ventricular hypertrophy) requiring surgical or procedural intervention.
  • Patient with prior catheter ablation procedure for the treatment of AF within the previous 6 months.
  • Patient has evidence of, or history of, 50% or more stenosis in any pulmonary vein.
  • Patient had a previous thoracic procedure resulting in sternal opening and/or pericardial opening (e.g., surgical ablation, coronary artery bypass graft [CABG], or valve repair).
  • Patient has a left atrial size > 6.0 cm measured on echocardiogram.
  • Patient has a left ventricular ejection fraction (LVEF) < 35%.
  • Patient requires treatment for CAD (coronary artery disease) or has untreated unstable angina.
  • Patient has a presence of esophageal fistula or esophageal stricture, untreated esophagitis, varices, dysphagia, or odynophagia caused by anatomical abnormality or other diseases contraindicating transesophageal echocardiography.
  • Patient has severe chronic obstructive pulmonary disease.
  • Patient has a known allergy or contraindication to Coumadin (warfarin) therapy, or inability to comply with Coumadin (warfarin) therapy.
  • Patient has a known allergy or contraindication to complying with antiarrhythmic (Class IA, IC, III) therapy.
  • Patient has an acute illness or active systemic infection or sepsis.
  • Patient has a co-morbidity with life expectancy of less than one year or protocol non-compliance that would limit follow-up.
  • Patient is geographically remote and/or unable to return for follow-up examinations.
  • Patient is pregnant or is planning to become pregnant during the study.
  • Patient is enrolled in any concurrent study.
Both
18 Years and older
 
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00415558
Maquet Cardiovascular, Maquet Cardiovascular
VR2049541
Maquet Cardiovascular
 
Principal Investigator: Li Poa, MD Enloe Medical Center
Principal Investigator: Dudley Hudspeth, MD Banner Desert Medical Center
Principal Investigator: Daniel Bethencourt, MD Long Beach Memorial Medical Center
Principal Investigator: Niloo Edwards, MD University of Wisconsin Hospitals and Clinics
Principal Investigator: Norbert Baumgartner, MD Covenant Medical Center
Maquet Cardiovascular
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP