RESOLVE-AF

Principal Investigator:
Norbert Baumgartner, MD

Sub-Investigator(s):
Peter Fattal MD
Christopher Genco MD
Luigi Maresca MD

Sponsor:
Guidant

Study:
VR2049541 Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in the Minimally Invasive Surgical Procedure

Objective:
The purpose of this study is to evaluate the safety and effectiveness of the Guidant Microwave Ablation System to treat symptomatic paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation is defined as an intermittent (alternating) rapid irregular atrial rhythm of the heart. The Sponsor’s probe uses microwave energy to create lesions on the heart muscle. These lesions will turn into scars that may create new paths for the electrical currents of your heart. This may stop the atrial fibrillation. This probe has not yet been approved to treat paroxysmal atrial fibrillation, it is approved to “ablate cardiac tissue” but is considered experimental for the purpose of specifically ablating atrial fibrillation. You are being invited to participate in this research study because you have symptomatic paroxysmal atrial fibrillation (symptomatic means that you have complaints from atrial fibrillation which may include but are not limited to palpitations, lightheadedness, fatigue, shortness of breath or chest pain).

Inclusion/Exclusion Criteria

Inclusion:

Patient is ≥ 18 years old.
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 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 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, agrees to its provisions and provided written informed consent.

Exclusion:

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, CABG, or valve repair).
Patient has a left atrial size > 6.0 cm measured on echocardiogram (documented within the previous 6 months).
Patient has a left ventricular ejection fraction (LVEF) <35% (documented within the previous 6 months).
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 noncompliance 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.
Pre-Treatment Procedural Exclusion
Presence of left atrial or left atrial appendage thrombus (assessed intra-operatively by the investigator and documented by intra-operative TEE).

STUDY PURPOSE
This clinical study is a prospective, un-blinded, single arm feasibility study that will be conducted at up to 6 investigational sites in the United States. The study population includes patients diagnosed with at least 2 documented episodes of symptomatic paroxysmal atrial fibrillation for the month preceding study entry. The diagnosed atrial fibrillation will be unrelated to an underlying medical etiology and unrelated to structural heart disease requiring surgical or procedural intervention. Patients must be refractory or intolerant to at least one antiarrhythmic (Class IA, IC, III) drug preceding study entry. Patients will be qualified for the study if they meet study eligibility criteria, which include agreeing to participate in the study and signing an informed consent. Potential patients must be screened and meet all of the eligibility criteria as listed in this protocol. Once patients are qualified for the clinical study, they will be consented prior to enrollment in the study. All study patients will receive microwave ablation to treat their symptomatic paroxysmal AF. The Microwave Ablation System will be used during a minimally invasive surgical procedure on a beating heart in order to ablate a specified lesion pattern. All patients will also receive antiarrhythmic therapy during the first three months of follow-up. After treatment initiation Day 0 (defined as the day of surgery) patients will return for follow-up assessments at Months 1, 3, 6, 9 and 12. Within the first 3 months (Day 0 to Month 3) unlimited adjustments may be made to the antiarrhythmic drugs in order to obtain optimal medical therapy and the patient is allowed to undergo electrical or pharmacological cardioversions. The prescribed antiarrhythmic therapy will be discontinued after completing the 3-month follow-up visit and no further electrical or pharmacological cardioversions may be attempted. Beginning at the 3-month visit, patients will enter the evaluation phase of the study, ending with the 12-month visit.

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