Effect of Right Ventricular Lead Position on Defibrillation Threshold

Ventricular Tachycardia Clinical Trial

Official title:

Effect of Right Ventricular Lead Position on Defibrillation Threshold

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02844127
• Other study ID #: OhioHealth 16-0029
• Status: Withdrawn
• Phase: N/A
• First received: July 8, 2016
• Last updated: September 18, 2017
• Start date: November 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: September 2017
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
United States	OhioHealth Grant Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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