Effect of Right Ventricular Lead Position on Defibrillation Threshold

NCT ID: NCT02844127

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-04-04

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.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Implantable Cardioverter Defibrillator (ICD)

Intervention Type: 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.

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

Group Type: OTHER

Implantable Cardioverter Defibrillator (ICD)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth J Rials, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

OhioHealth Grant Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

OhioHealth 16-0029

Identifier Type: -

Identifier Source: org_study_id