Heart Failure, CongestiveNCT00385749
Right Ventricular Defibrillation Lead Select Site Study
A study testing RV apical vs RV septal defibrillation threshold testing in people with Heart Failure, Congestive and Tachycardia, Ventricular, run by Associates in Cardiology, PA at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Congestive, Tachycardia, Ventricular
- What is being tested?
- RV apical vs RV septal defibrillation threshold testing
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard indications for ICD placement (AHA/ACC guidelines)
Who cannot join
- Inability to consent
- age less than 21 years
- inability to participate in study follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Holy Cross Hospital of Silver Spring
Silver Spring, Maryland, 20910
Michael A Lincoln, MD
About this study
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.
Read the 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.
- Being tested
- RV apical vs RV septal defibrillation threshold testing
- Keywords
- Implanted cardioverter defibrillator, congestive heart failure, right ventricular lead placement, select site pacing
- Medical subject headings
- Heart Failure, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV apical vs RV septal defibrillation threshold testingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute defibrillation thresholds
Secondary outcomes (6)
LV function (LVEF)
pacing thresholds
sensing thresholds
LV diameter
NYHA class
weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startOct 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associates in Cardiology, PA
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Michael A Lincoln, MD, Principal investigator, Holy Cross Hospital of Silver Spring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385749
- Sponsor's protocol ID
- RVLeadSelectSite
- Status last verified
- Oct 2007
- First submitted
- 10 Oct 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Defibrillation Lead Select Site Study
- ClinicalTrials.gov ID
- NCT00385749
- Acronym / sponsor ID
- RVLeadSelectSite
- Keywords
- Implanted cardioverter defibrillator, congestive heart failure, right ventricular lead placement, select site pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Associates in Cardiology, PAUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Standard indications for ICD placement (AHA/ACC guidelines)
Key exclusion criteria (3 listed)
- Inability to consent
- age less than 21 years
- inability to participate in study follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV apical vs RV septal defibrillation threshold testing | Device | – |
Primary outcome
Acute defibrillation thresholds
6 secondary outcomes
LV function (LVEF)
pacing thresholds
sensing thresholds
LV diameter
NYHA class
weight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Lincoln, MD principal investigator
Holy Cross Hospital of Silver Spring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV apical vs RV septal defibrillation threshold testing in people with Heart Failure, Congestive and Tachycardia, Ventricular, run by Associates in Cardiology, PA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Lincoln, MD (301-681-5700, mlincoln@associatesincardiology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute defibrillation thresholds. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2007; AzTrials last refreshed its copy on 29 Oct 2026.