Effect of Right Ventricular Lead Position on Defibrillation Threshold

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.

Study Overview

• Status: Withdrawn
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Procedure: Implantable Cardioverter Defibrillator (ICD)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43215
      • OhioHealth Grant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Apex First; Patients born in odd-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the apex and then in the septum. Final lead position will be determined at the discretion of the implanting physician.	Procedure: Implantable 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.
Other: Septum First; Patients born in even-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the septum and then in the apex. Final lead position will be determined at the discretion of the implanting physician	Procedure: Implantable 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of each surgery through study completion, or up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of each surgery through study completion, or up to 12 months

Collaborators and Investigators

• Sponsor: OhioHealth
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Seth J Rials, MD, PhD, OhioHealth

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: OhioHealth 16-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Because this is a pilot study with limited data collection, data will not need to be shared.