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Right Ventricular Defibrillation Lead Select Site Study

NCT ID: NCT00385749

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure, Congestive Tachycardia, Ventricular

Keywords

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Implanted cardioverter defibrillator congestive heart failure right ventricular lead placement select site pacing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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RV apical vs RV septal defibrillation threshold testing

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Associates in Cardiology, PA

OTHER

Sponsor Role lead

Principal Investigators

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Michael A Lincoln, MD

Role: PRINCIPAL_INVESTIGATOR

Holy Cross Hospital of Silver Spring

Locations

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Holy Cross Hospital of Silver Spring

Silver Spring, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael A Lincoln, MD

Role: CONTACT

Phone: 301-681-5700

Email: [email protected]

Other Identifiers

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RVLeadSelectSite

Identifier Type: -

Identifier Source: org_study_id