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History of Changes for Study: NCT00385749
Right Ventricular Defibrillation Lead Select Site Study
Latest version (submitted October 30, 2007) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 10, 2006 None (earliest Version on record)
2 April 3, 2007 Study Status
3 October 30, 2007 Recruitment Status, Study Status, Study Design and Study Identification
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Study NCT00385749
Submitted Date:  October 10, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: RVLeadSelectSite
Brief Title: Right Ventricular Defibrillation Lead Select Site Study
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2006
Overall Status: Recruiting
Study Start: October 2006
Primary Completion:
Study Completion: December 2008
First Submitted: October 10, 2006
First Submitted that
Met QC Criteria:
October 10, 2006
First Posted: October 11, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 10, 2006
Last Update Posted: October 11, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Associates in Cardiology, PA
Responsible Party:
Collaborators: Medtronic
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Open or close this module Conditions
Conditions: Heart Failure, Congestive
Tachycardia, Ventricular
Keywords: Implanted cardioverter defibrillator
congestive heart failure
right ventricular lead placement
select site pacing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 98
Open or close this module Arms and Interventions
Intervention Details:
Device: RV apical vs RV septal defibrillation threshold testing
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Acute defibrillation thresholds
Secondary Outcome Measures:
1. LV function (LVEF)
2. pacing thresholds
3. sensing thresholds
4. LV diameter
5. NYHA class
6. weight
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Michael A Lincoln, MD
Telephone: 301-681-5700
Email: mlincoln@associatesincardiology.com
Study Officials: Michael A Lincoln, MD
Principal Investigator
Holy Cross Hospital of Silver Spring
Locations: United States, Maryland
Holy Cross Hospital of Silver Spring
[Recruiting]
Silver Spring, Maryland, United States, 20910
Contact:Principal Investigator: Michael A Lincoln, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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