Right Ventricular Defibrillation Lead Select Site Study
Primary Purpose
Heart Failure, Congestive, Tachycardia, Ventricular
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RV apical vs RV septal defibrillation threshold testing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Implanted cardioverter defibrillator, congestive heart failure, right ventricular lead placement, select site pacing
Eligibility Criteria
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
Sites / Locations
- Holy Cross Hospital of Silver SpringRecruiting
Outcomes
Primary Outcome Measures
Acute defibrillation thresholds
Secondary Outcome Measures
LV function (LVEF)
pacing thresholds
sensing thresholds
LV diameter
NYHA class
weight
Full Information
NCT ID
NCT00385749
First Posted
October 10, 2006
Last Updated
October 30, 2007
Sponsor
Associates in Cardiology, PA
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00385749
Brief Title
Right Ventricular Defibrillation Lead Select Site Study
Official Title
Right Ventricular Defibrillation Lead Select Site Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Associates in Cardiology, PA
Collaborators
Medtronic
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Tachycardia, Ventricular
Keywords
Implanted cardioverter defibrillator, congestive heart failure, right ventricular lead placement, select site pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
RV apical vs RV septal defibrillation threshold testing
Primary Outcome Measure Information:
Title
Acute defibrillation thresholds
Secondary Outcome Measure Information:
Title
LV function (LVEF)
Title
pacing thresholds
Title
sensing thresholds
Title
LV diameter
Title
NYHA class
Title
weight
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Lincoln, MD
Phone
301-681-5700
Email
mlincoln@associatesincardiology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Lincoln, MD
Organizational Affiliation
Holy Cross Hospital of Silver Spring
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Cross Hospital of Silver Spring
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael A Lincoln, MD
12. IPD Sharing Statement
Learn more about this trial
Right Ventricular Defibrillation Lead Select Site Study
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