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Right Ventricular Defibrillation Lead Select Site Study

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ClinicalTrials.gov Identifier: NCT00385749
Recruitment Status : Unknown
Verified October 2007 by Associates in Cardiology, PA.
Recruitment status was:  Recruiting
First Posted : October 11, 2006
Last Update Posted : November 1, 2007
Sponsor:
Collaborator:
Medtronic
Information provided by:
Associates in Cardiology, PA

Tracking Information
First Submitted Date  ICMJE October 10, 2006
First Posted Date  ICMJE October 11, 2006
Last Update Posted Date November 1, 2007
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
Acute defibrillation thresholds
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
  • LV function (LVEF)
  • pacing thresholds
  • sensing thresholds
  • LV diameter
  • NYHA class
  • weight
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Right Ventricular Defibrillation Lead Select Site Study
Official Title  ICMJE Right Ventricular Defibrillation Lead Select Site Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure, Congestive
  • Tachycardia, Ventricular
Intervention  ICMJE Device: RV apical vs RV septal defibrillation threshold testing
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2006)
98
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00385749
Other Study ID Numbers  ICMJE RVLeadSelectSite
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Associates in Cardiology, PA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Michael A Lincoln, MD Holy Cross Hospital of Silver Spring
PRS Account Associates in Cardiology, PA
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP