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Eligibility
for people ages 18 years and up
Location
at San Francisco, California
Dates
study started
Principal Investigator

Description

Summary

The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided lead placement improves clinical outcomes for patients needing cardiac resynchronization therapy (CRT) compared to traditional posterolateral left ventricular lead placement.

Official Title

Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy (MUGA-CRT)

Details

Heart failure (HF) has a prevalence of five million individuals in the United States. Approximately 25-30% of patients with HF due to left ventricular (LV) systolic dysfunction have prolonged QRS. Prolonged QRS duration (>120ms) on ECG in HF patients is associated with increased morbidity and mortality.

Delayed electrical activation of the LV translates to temporal delay in ventricular contraction. This is referred to as mechanical dyssynchrony. Patients with advanced HF, low ejection fraction (EF) of less than 35% and QRS of more than 120ms are indicated for cardiac resynchronization therapy (CRT). While most patients undergoing CRT implantation show dramatic improvement in HF symptoms, 30-40% of the HF patients undergoing CRT placement do not show a clinical response. The site of placement of the LV lead has been shown to be an important determinant of the effects of CRT.

Measurement of left ventricular ejection fraction (LVEF) is performed using non-invasive measures such as the MUGA. By using the available information on left ventricular systolic function the investigators plan on investigating the effects of MUGA-guided versus traditional LV lead placement for CRT.

Keywords

Heart Failure Left Ventricular Dysfunction Cardiac Resynchronization Therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female, 18 years or older
  • Must have an approved indication for CRT implantation
  • Must have ischemic or nonischemic dilated cardiomyopathy
  • Must have symptomatic HF with a New York Association (NYHA) Classification of III or IV
  • Must be on optimal pharmacological therapy (this should include at the minimum, ACE inhibitor and beta-blocker therapy as tolerated.
  • Must have left ventricular ejection fraction (LVEF) of ≤35%
  • Must have ventricular conduction delay manifested as a QRS duration of>120msec
  • Must be able to provide informed consent for study participation and be willing to comply with follow-up tests and scheduled visits

You CAN'T join if...

  • HF diagnosis for less than 3 months
  • Physical limitations to ambulation
  • Life expectancy of less than six months
  • Pregnant or planning for pregnancy in the next 6 months (must have a negative pregnancy test 7 days prior to enrollment)

Location

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT02669290
Lead Scientist
Nitish Badhwar
Study Type
Interventional
Last Updated
January 2016