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Clinical Trials/NL-OMON37145
NL-OMON37145
Completed
Phase 4

Shockless Implant Evaluation - A prospective Randomized Clinical Study - SIMPLE

Boston Scientific0 sites230 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Ventriculaire Tachyarrhythmia - cardiac rythm disorder
Sponsor
Boston Scientific
Enrollment
230
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients indicated for an ICD or CRT\-D (according to indications at time of implant \- see Appendix E for indications at time of protocol writing) undergoing initial implant of a market released Guidant/Boston Scientific device (can be upgrade from pacemaker).;Age \>\= 18 years

Exclusion Criteria

  • Patient, who in the opinion of their treating physicians is ineligible for either strategy (DT or no testing);Patient on the active transplant list;Unwilling to provide written informed consent;Unavailable for Follow\-up;Pregnancy (or women of child\-bearing potential not taking or willing to take an effective method of contraception).;Anticipated right\-sided implantation of ICD generator;Participation in concomitant clinical study other than a registry

Outcomes

Primary Outcomes

Not specified

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