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Effect of Right Ventricular Lead Position on Defibrillation Threshold

Primary Purpose

Ventricular Tachycardia, Ventricular Fibrillation

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Implantable Cardioverter Defibrillator (ICD)

About this trial

This is an interventional other trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

OhioHealth Grant Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Apex First

Septum First

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02844127

First Posted

July 8, 2016

Last Updated

September 18, 2017

Sponsor

OhioHealth

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT02844127

Brief Title

Effect of Right Ventricular Lead Position on Defibrillation Threshold

Official Title

Effect of Right Ventricular Lead Position on Defibrillation Threshold

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Devices proposed for use in the protocol no longer used by physician

Study Start Date

November 2016 (undefined)

Primary Completion Date

April 4, 2017 (Actual)

Study Completion Date

April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OhioHealth

Collaborators

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia, Ventricular Fibrillation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apex First

Arm Type

Other

Arm Description

Arm Title

Septum First

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Implantable Cardioverter Defibrillator (ICD)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Defibrillator threshold

Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seth J Rials, MD, PhD

Organizational Affiliation

OhioHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

OhioHealth Grant Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Because this is a pilot study with limited data collection, data will not need to be shared.

Learn more about this trial

Effect of Right Ventricular Lead Position on Defibrillation Threshold

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