Ventriculaire Tachyarrhythmia - cardiac rythm disorder
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine if DT can be eliminated as a component of implantable cardioverter defibrillator (ICD) implantation, while still maintaining the clinical effectiveness of ICDs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the peri-operative safety of DT. Secundary objective has been fulfilled. | — |
Countries
Netherlands
Outcome results
None listed