Effect of Right Ventricular Lead Position on Defibrillation Threshold

NCT02844127 | Withdrawn

• 1 other identifier: OhioHealth 16-0029
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Apex First

OTHER

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)

Septum First

OTHER

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)

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.

Apex First; Septum First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

OhioHealth Grant Medical Center

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Seth J Rials, MD, PhD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 26, 2016
• Study Start: November 1, 2016
• Primary Completion: April 4, 2017
• Study Completion: April 4, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)