NL-OMON37145
Completed
Phase 4
Shockless Implant Evaluation - A prospective Randomized Clinical Study - SIMPLE
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.
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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