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

NCT00415558 | Terminated

• 1 other identifier: VR2049541
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Interventions

Microwave Ablation System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maquet Cardiovascular: lead

Study Sites (5)

Unknown Facility

Mesa, Arizona, United States

Location

Unknown Facility

Chico, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Saginaw, Michigan, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 25, 2006
• Study Start: May 1, 2007
• Last Updated: June 9, 2009

Record last verified: 2009-06

Locations

US (5)