Right Ventricular Defibrillation Lead Select Site Study

Heart Failure, Congestive Clinical Trial

Official title:

Right Ventricular Defibrillation Lead Select Site Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00385749
• Other study ID #: RVLeadSelectSite
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2006
• Last updated: October 30, 2007
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: October 2007
• Source: Associates in Cardiology, PA
• Contact: Michael A Lincoln, MD
• Phone: 301-681-5700
• Email: mlincoln[@]associatesincardiology.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholds(DFTs), and that they may have long term advantages in reducing left ventricular dysfunction.

Description:

The new studies "Right Ventricular Lead/Select Site Registry" and "Right Ventricular Lead/Select Site Registry: Acute Study" are studies designed to look at alternate lead locations for defibrillation leads for ICDs. The registry is designed to capture data from patients who have already undergone implant, so as to be able to publish long term data on defibrillation thresholds, pacing thresholds and left ventricular function. This will include both patients from the acute study, and those patients in whom leads have already been placed, and the exact lead location is known. The acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads. This study involves a direct comparison of two different sites in the same patient; using defined criteria for implant location (see protocol). The acute study is anticipated to enroll 34 patients, but the registry to collect ongoing data will be larger, encompassing previously implanted patients, with an expected sample size of 61 total in the registry for data collection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Standard indications for ICD placement (AHA/ACC guidelines)

Exclusion Criteria:

• Inability to consent

• age less than 21 years

• inability to participate in study follow-up

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• RV apical vs RV septal defibrillation threshold testing

Locations

Country	Name	City	State
United States	Holy Cross Hospital of Silver Spring	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Associates in Cardiology, PA	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute defibrillation thresholds
Secondary	LV function (LVEF)
Secondary	pacing thresholds
Secondary	sensing thresholds
Secondary	LV diameter
Secondary	NYHA class
Secondary	weight