ATTAIN Stability Quad Trial

Linkhttps://clinicaltrials.gov/ct2/show/NCT03099655?term=attain+stability+quad&rank=1

Principal Investigator:  Rudolph F. Evonich, III, MD

  • You are being asked to take part in this study because you are having a new CRT-D/CRT-P or are being upgraded to a CRT-D/CRT-P
  • The lead is very similar to the lead that would be used if you weren’t in the study.  The difference is the way it attaches to the vein inside your heart to keep it from moving out of place.
  • There will be no extra charge for this procedure because you are in the study.  You will still be responsible for any co-pays or deductibles as usual.
  • In over 4000 patients in Europe there have been no lead dislodgements or vein perforations
  • The study will enroll up to 471 people in the trial at 56 centers Worldwide
  • Your participation is voluntary. You don’t have to participate in the study and it will not affect your medical care if you choose not to participate.
  • You will not be randomized as everyone who agrees to be in the study will have the attempt to have this lead implanted.
  • The purpose of this study is to prove the safety and efficacy of the 4798 LV lead model.
  • You will be required to have an occlusive venogram during the procedure, this provides a better picture of the veins in your hearts
  • If you choose to take part in this study you will be asked to come for extra study visits before the procedure(Enrollment), 3 months after the procedure(Regular Care), 6 months and every 6 months(Regular Care) until the study ends.  (Approximately 2 years.)
  • The visits will include a little more than what is required at a standard Pacer clinic visit
  • You will be reminded at each visit to let Dr. Evonich, the Pacer Clinic 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.