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Right Ventricular Defibrillation Lead Select Site Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Associates in Cardiology, PA.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385749
First Posted: October 11, 2006
Last Update Posted: November 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Associates in Cardiology, PA
  Purpose
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.

Condition Intervention
Heart Failure, Congestive Tachycardia, Ventricular Device: RV apical vs RV septal defibrillation threshold testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Right Ventricular Defibrillation Lead Select Site Study

Resource links provided by NLM:


Further study details as provided by Associates in Cardiology, PA:

Primary Outcome Measures:
  • Acute defibrillation thresholds

Secondary Outcome Measures:
  • LV function (LVEF)
  • pacing thresholds
  • sensing thresholds
  • LV diameter
  • NYHA class
  • weight

Estimated Enrollment: 98
Study Start Date: October 2006
Estimated Study Completion Date: December 2008
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385749


Contacts
Contact: Michael A Lincoln, MD 301-681-5700 mlincoln@associatesincardiology.com

Locations
United States, Maryland
Holy Cross Hospital of Silver Spring Recruiting
Silver Spring, Maryland, United States, 20910
Principal Investigator: Michael A Lincoln, MD         
Sponsors and Collaborators
Associates in Cardiology, PA
Medtronic
Investigators
Principal Investigator: Michael A Lincoln, MD Holy Cross Hospital of Silver Spring
  More Information

ClinicalTrials.gov Identifier: NCT00385749     History of Changes
Other Study ID Numbers: RVLeadSelectSite
First Submitted: October 10, 2006
First Posted: October 11, 2006
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by Associates in Cardiology, PA:
Implanted cardioverter defibrillator
congestive heart failure
right ventricular lead placement
select site pacing

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes