aMAZE Trial (Alternative-MAZE Procedure)

Principal Investigator:  Rudolph Evonich, III, MD

Clinical Trials - aMAZE
aMAZE Trial Website

LARIAT Device  

  • You are being asked to take part in this study because you have been diagnosed with persistent or long-standing persistent AF, you are already planning to undergo an RF Ablation to treat that condition and Dr. Evonich has determined you are a good candidate for this study
  • The study will be conducted at 50 sites and enroll up to 600 subjects
  • You will be randomized to either the extra LARIAT procedure and PVI or PVI alone. (2:1)
  • PVI alone-requires no extra procedures other than follow-up visits here in Marquette
  • LARIAT and PVI will require you to undergo a LARIAT procedure first with the PVI procedure 30 days later.  Your insurance will be billed for both procedures and you will be responsible for any co-pays or deductibles normally associated with these procedures.  The LARIAT procedure requires a hospital stay with a drain placed after the procedure.
  • The purpose of this study is to evaluate the idea that isolating the Left Atrial Appendage increases the effectiveness of the ablation and leads to a better outcome for treatment of you’re a-fib.
  • The LARIAT device is already FDA approved in the US but not for this treatment indication.
  • If you choose to take part in this study you will be asked to come for extra study visits before the procedure(s), at 30 days, 3 months, 6 months and 1 year
  • You will be reminded at each visit to let Dr. Evonich or the study coordinator know if you have experienced any problems since being enrolled in the study.
  • The study doctor and study coordinator will collect information about you and your medical history including all treatments/hospitalizations/re-ablations.
  • You will have a Holter Monitor placed at 6 and 12 months with instructions on how to return it to the study center
  • At your 3 month visit you may be given a small device to record your heart rhythm when you experience symptoms. You will be given instructions on how to use the device and apply it to record your heart rhythm when you are having symptoms.
  • If you are randomized to the LARIAT procedure you will also have to undergo another TEE  to look at the the Left Atrial Appendage and how well the closure device worked.