Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.
Detailed description
The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD). There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.
Interventions
PROCEDUREImplantable Cardioverter Defibrillator (ICD)
Patients will receive an Implantable Cardioverter Defibrillator (ICD), with the leads implanted in either the apex or the septum as the first location. After defibrillation threshold is determined, the leads position will be changed to the second location and DFT will be determined again.
Sponsors
Abbott Medical Devices
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator * Left-sided implant * Single coil or dual coil (single coil for testing) * Age ≥ 18 years of age * Ability to consent * Medically stable, in the opinion of the implanting physician, to undergo defibrillation safety margin testing * Procedure performed under conscious sedation * English-speaking
Exclusion criteria
* Patient unable to understand and consent to the procedure on his or her own * Pregnant or breastfeeding patients * New York Heart Association (NYHA) Class IV * Patients with pre-existing RV leads * Pacemaker dependent * Patient medically unstable to undergo defibrillation testing (e.g., high risk for deep sedation; patients that develop respiratory compromise or hemodynamic instability from the sedation) * Patients that require general anesthesia instead of conscious sedation * Patients \<18 years of age * Non-English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defibrillator threshold | At the time of each surgery through study completion, or up to 12 months | Defibrillator threshold (DFT) will be determined at the time of implantation for each patient at the apex and the septum. A difference of \>4 joules will be considered clinically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with improved defibrillation threshold at the septum versus the apex | At the time of each surgery through study completion, or up to 12 months | The percentage of patients that have an improved safety profile from septal implantation versus apical implantation will be calculated. Improved safety profile is defined as a defibrillation threshold increase of \>4 joules. |
Countries
United States
Outcome results
None listed