Effect of Right Ventricular Lead Position on Defibrillation Threshold

OhioHealth

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Conditions

Ventricular Tachycardia Ventricular Fibrillation

Interventions

Implantable Cardioverter Defibrillator (ICD)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

OhioHealth Grant Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Defibrillator threshold

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.

Time frame: At the time of each surgery through study completion, or up to 12 months

Secondary Outcomes

Percentage of patients with improved defibrillation threshold at the septum versus the apex

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.

Time frame: At the time of each surgery through study completion, or up to 12 months

Data from ClinicalTrials.gov

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