SYMPLICITY

Principal Investigator: Rudolph Evonich, III, MD

Clinical Trials - SYMPLICITY 

  • You have decided to undergo a Cryo-Ablation to treat that condition and are willing to be randomized to possibly have another procedure called a Renal Denervation procedure to treat your hypertension in hopes it makes the cryo-ablation procedure more effective.
  • The study will enroll up to 245 people in the trial at 12 centers in the United States
  • You will be randomized to either the renal nerve denervation procedure along with your Ablation or the ablation alone.  Both groups will have a LINQ device heart monitor implanted also.   This device can monitor any heart arrhythmias for the duration of your study participation.  (Up to 3 years)
  • The purpose of this study is to provide additional information about the safety and treatment effect when two medical devices are used together to treat your AF.
  • You will be required to have a CT scan of your kidneys to determine if the arteries supplying the kidneys are appropriate for treatment.  You may also need to have an Echocardiogram if you have not had one in the last year.
  • If you are randomized to the treatment group you will have a renal angiogram before the Renal Denervation procedure will begin to confirm the CT findings.
  • The Ablation catheter is approved (Use for the general public) for paroxysmal AF but is considered experimental if you have been diagnosed with Persistent AF.
  • The renal denervation catheters are not already approved in the United States, which means it has not been approved by the FDA and is not available to the general public.
  • If you choose to take part in this study you will be asked to come for extra study visits before the procedure, 1 month after the procedure, 6 months and every 6 months until the study ends.  (Approximately 2 years.)
  • 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.
  • At the 6 month visit you will undergo a Renal Ultrasound if you were randomized to the treatment group.
  • You will be required to have your LINQ interrogated monthly from home (Instructions will be provided) except for the months you come in person to the clinic.
  • The LINQ device will be removed at the end of the study.