N/A
N=2,500
Shockless Implant Evaluation
Ventricular Fibrillation · Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT00800384 ↗Enrolled (actual)
2,500
Serious AEs
62.6%
Results posted
Dec 2015
Primary outcome: Primary: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death — 90; 104 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantable defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death |
90; 104 | — |
| SECONDARY Perioperative Complication Rate |
69; 81 | — |
Summary
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Exclusion Criteria
- Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
- Patients on active transplant list
- Patients unwilling to provide informed consent
- Patients not available for follow-up
- Pregnancy or women of child bearing potential not following an effective method of contraception
- Anticipated right sided implantation of the ICD generator
Data sourced from ClinicalTrials.gov (NCT00800384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.