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Withdrawn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)
Sponsored by
About this trial
This is an interventional other trial for Ventricular Tachycardia
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
Sites / Locations
- OhioHealth Grant Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
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
No
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
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.
Arm Title
Septum First
Arm Type
Other
Arm Description
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
No
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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