AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of AtriCure's CryoICE Ablation System in performing the Cox-Maze III Lesion set surgical procedure, in conjunction with LAA exclusion using ArtiCure's AtriClip device.

The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is greater than or equal to 18 years of age.
  • Subject has history of persistent or long-standing persistent atrial fibrillation:
    • AF documentation requirement for persistent AF: Physician’s note indicating continuous AF > 7 days but no more than 1 year, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure;
    • AF documentation requirement for longstanding persistent AF: physician’s note indicating at least 1 year of continuous AF, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure. The performance of a successful cardioversion (sinus rhythm > 30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as long-standing persistent.
  • Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, patent foramen ovale repair, and/or atrial septal defect.
  • Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
  • Subject is willing and able to provide written informed consent.
  • Subject has a life expectancy of at least 5-years.
  • Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

  • Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
  • Previous surgical Maze procedure.
  • Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, AV nodal reentry.
  • Prior cardiac surgery (Redo).
  • Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
  • Class IV NYHA heart failure symptoms.
  • Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit.
  • Documented ST elevation MI within the 6 weeks prior to study enrollment.
  • Need for emergent cardiac surgery (i.e., cardiogenic shock).
  • Known carotid artery stenosis greater than 80%.
  • Documented (continuous) AF duration of greater than ten years.
  • LA diameter > 7 cm by TTE within 12 weeks (90 days) of procedure.
  • Current diagnosis of active systemic infection.
  • Severe peripheral arterial occlusive disease defined as claudication with minimal exertion.
  • Renal failure requiring dialysis or hepatic failure.
  • A known drug and/or alcohol addiction.
  • Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study.
  • Pregnancy or desire to get pregnant within 12-months of the study treatment.
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
  • Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia.
  • Subjects who have been treated with thoracic radiation.
  • Subjects in current chemotherapy.
  • Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
  • Subjects with known connective tissue disorders.
  • Subjects with known hypertrophic obstructive cardiomyopathy.
  • Subjects with known cold agglutinin.
  • Patient has a condition that in the opinion of the investigator, may jeopardize the patient’s wellbeing and/or the soundness of this clinical study.
  • Subject has a contraindication to post-operative anticoagulation; Patient has history of blood dyscrasia or clotting disorder (i.e., Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).

Eligibility last updated 9/21/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Juan Crestanello, M.D.

Contact us for the latest status

Contact information:

Brandon Dunagan CCRP

(507) 255-7566

Dunagan.Brandon@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20517577

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