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Cardiovascular Medicine - Active Clinical Trials
PROVIDE


Primary Investigator: Richard Weachter, MD

Study Coordinator: Jane Spencer, RN

Status: Closed to enrollment; follow-up only

Study Title: Programming Implantable Cardioverter Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock (PROVIDE)

Purpose: The purpose of this research study is to see if making changes to the settings of an ICD can lower the number of shocks people may receive without increasing heart risk. It is planned that about 1,600 people 18 years old or older who have a St. Jude Medical ICD/CRT-D will be enrolled in the study.

Inclusion Criteria
·         Patient is enrolled within 30 days of implant with a market-released St Jude Medical CurrentTM, PromoteTM, or a newer device for a primary prevention indication for ICD/CRT-D.
·         Patient is willing to comply with the study procedure.
·         Patient is able to be programmed to either control or experimental group of parameters specified in Appendix A and B.
·         Patient had spontaneous VT or VF prior to the implant. VT is considered an exclusion if:
      
o   VT lasted for ³ 30 seconds.
      
o    VT was hemodynamically unstable.
      
o    VT required external cardioversion.
·         Patient had inducible sustained VT <181 bpm in an electrophysiology test.
·         Patient had an ICD or CRT-D device prior to their currently implanted device.
·         Patient is enrolled in any other clinical investigation that includes an active treatment arm.
·         Patient's life expectancy is less than 24 months.
·         Patient is a candidate for cardiac transplant.
·         Patient is pregnant.
·         Patient's age at enrollment is less than 18 years.

Actions:
       Call Alisa Lau-Sieckman (beeper: 573-443-9259) and/or on-call research nurse (on-call beeper 573-499-8084) or Dr. Weachter for notification that subject has been admitted to the hospital or for questions regarding device.




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