N/A
N=100
Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02027883 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Sustained Ventricular Fibrillation — 38; 35 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nominal T shock setting (Device); Educated T shock setting (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James Merrill
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Ventricular Fibrillation |
38; 35 | — |
| SECONDARY Factors |
30; 28; 8; 7; 8; 12 | — |
Summary
As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is crucial. Multiple induction attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting the number of attempts will allow for better lead stability throughout the procedure and a more straightforward implant process.
Investigator proposes a detailed documentation of success rates from various Ventriculart Fibrillation induction methods during implant of Medtronic defibrillation capable devices.
Eligibility Criteria
Inclusion Criteria
- All patients undergoing Medtronic ICD or Cardiac Resynchronization Therapy-Defibrillator implant (initial implant or generator replacement) will be included.
Exclusion Criteria
- Any patient who is medically unstable and testing is deemed unsafe by physician will be excluded from this study.
Data sourced from ClinicalTrials.gov (NCT02027883). 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.