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

NCT ID: NCT00415558

Last Updated: 2009-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Microwave Ablation System

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maquet Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Maquet Cardiovascular

Principal Investigators

Li Poa, MD

Role: PRINCIPAL_INVESTIGATOR

Enloe Medical Center

Dudley Hudspeth, MD

Role: PRINCIPAL_INVESTIGATOR

Banner Desert Medical Center

Daniel Bethencourt, MD

Role: PRINCIPAL_INVESTIGATOR

Long Beach Memorial Medical Center

Niloo Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Hospitals and Clinics

Norbert Baumgartner, MD

Role: PRINCIPAL_INVESTIGATOR

Covenant Medical Center

Locations

Mesa, Arizona, United States

Chico, California, United States

Long Beach, California, United States

Saginaw, Michigan, United States

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

VR2049541

Identifier Type: -

Identifier Source: org_study_id