Clinical trial NCT00415558: Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2006-12-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Chico
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Saginaw
country: United States
state: Michigan
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Enloe Medical Center
name: Li Poa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Banner Desert Medical Center
name: Dudley Hudspeth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Beach Memorial Medical Center
name: Daniel Bethencourt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin Hospitals and Clinics
name: Niloo Edwards, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Covenant Medical Center
name: Norbert Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
References: