Recruiting

Defibrillation Lead

Sponsor:

Associates in Cardiology, PA

Code:

NCT00385749

Conditions

Heart Failure, Congestive

Tachycardia, Ventricular

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

RV apical vs RV septal defibrillation threshold testing

Study Details

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.

Conditions

Heart Failure, Congestive

Tachycardia, Ventricular

Study ID

NCT00385749

Start date

Oct, 2006

Status verified date

Oct, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

98 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

RV apical vs RV septal defibrillation threshold testing

Primary outcome measure

  • Acute defibrillation thresholds [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Michael A Lincoln, MD

301-681-5700mlincoln@associatesincardiology.com

Locations

Holy Cross Hospital of Silver Spring

Recruiting

Silver Spring, Maryland, United States, 20910

Principal Investigator:

Michael A Lincoln, MD

More Information

Sponsor

Associates in Cardiology, PA

Last update posted

Nov 1, 2007

Last verified

Oct, 2007

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Associates in Cardiology, PA on 2007-11-01.