- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385749
Right Ventricular Defibrillation Lead Select Site Study
October 30, 2007 updated by: Associates in Cardiology, PA
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael A Lincoln, MD
- Phone Number: 301-681-5700
- Email: mlincoln@associatesincardiology.com
Study Locations
-
-
Maryland
-
Silver Spring, Maryland, United States, 20910
- Recruiting
- Holy Cross Hospital of Silver Spring
-
Principal Investigator:
- Michael A Lincoln, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Acute defibrillation thresholds
|
Secondary Outcome Measures
Outcome Measure |
---|
weight
|
LV function (LVEF)
|
pacing thresholds
|
sensing thresholds
|
LV diameter
|
NYHA class
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A Lincoln, MD, Holy Cross Hospital of Silver Spring
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
November 1, 2007
Last Update Submitted That Met QC Criteria
October 30, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RVLeadSelectSite
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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