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

University of California San Francisco (UCSF)

Status

Terminated

Conditions

Cardiac Resynchronization Therapy

Heart Failure

Left Ventricular Dysfunction

Treatments

Other: Guided

Other: Non-guided

Study type

Interventional

Funder types

Other

Identifiers

NCT02669290

10-04791

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)