NCT00385749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

October 10, 2006

Last Update Submit

October 30, 2007

Conditions

Heart Failure, CongestiveTachycardia, Ventricular

Keywords

Implanted cardioverter defibrillatorcongestive heart failureright ventricular lead placementselect site pacing

Outcome Measures

Primary Outcomes (1)

  • Acute defibrillation thresholds

Secondary Outcomes (6)

  • LV function (LVEF)

  • pacing thresholds

  • sensing thresholds

  • LV diameter

  • NYHA class

  • +1 more secondary outcomes

Interventions

RV apical vs RV septal defibrillation threshold testingDEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Standard indications for ICD placement (AHA/ACC guidelines)

You may not qualify if:

  • Inability to consent
  • age less than 21 years
  • inability to participate in study follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy Cross Hospital of Silver Spring

Silver Spring, Maryland, 20910, United States

RECRUITING

MeSH Terms

Conditions

Heart FailureTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesTachycardiaArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael A Lincoln, MD

    Holy Cross Hospital of Silver Spring

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Lincoln, MD

CONTACT

301-681-5700mlincoln@associatesincardiology.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

October 1, 2006

Study Completion

December 1, 2008

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

US(1)