Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
Information source: Maquet Cardiovascular
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Microwave Ablation System (Device)
Phase: N/A
Status: Suspended
Sponsored by: Maquet Cardiovascular Official(s) and/or principal investigator(s):
Li Poa, MD, Principal Investigator, Affiliation: Enloe Medical Center
Dudley Hudspeth, MD, Principal Investigator, Affiliation: Banner Desert Medical Center
Daniel Bethencourt, MD, Principal Investigator, Affiliation: Long Beach Memorial Medical Center
Niloo Edwards, MD, Principal Investigator, Affiliation: University of Wisconsin Hospitals and Clinics
Norbert Baumgartner, MD, Principal Investigator, Affiliation: Covenant Medical Center
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mesa, Arizona, United States
Long Beach, California, United States
Chico, California, United States
Saginaw, Michigan, United States
Madison, Wisconsin, United States
Additional Information
Starting date: May 2007
Last updated: January 24, 2008
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