N/A
N=2,120
SAFEty of Two Strategies of ICD Management at Implantation
Ventricular Fibrillation · Ventricular Flutter · Sudden Cardiac Death
Bottom Line
View on ClinicalTrials.gov: NCT00661037 ↗Enrolled (actual)
2,120
Serious AEs
18.2%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up — 18; 16 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Implantable defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up |
18; 16 | — |
| SECONDARY Severe Intra-operative Complications |
8; 4 | — |
| SECONDARY Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up |
10; 12 | — |
Summary
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator
Eligibility Criteria
Inclusion Criteria
- first implantation of ICD or CRT-D
- Patients undergoing upgrade to ICD or CRT-D from pacemaker
- Patients undergoing upgrade to CRT-D from CRT
- Age 18 or above, or legal age to give written informed consent
Exclusion Criteria
- Patients who do not give consent to treat their data.
Data sourced from ClinicalTrials.gov (NCT00661037). 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.