Clinical trial NCT02669290: Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy
Official title: Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy (MUGA-CRT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Left Ventricular Dysfunction
Cardiac Resynchronization Therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Six minute walk test (6MWT)
timeFrame: Baseline to six months.
Secondary outcomes:
measure: Change in New York Heart Association (NYHA) class.
timeFrame: Baseline to six months.
measure: Quality-of-Life Questionnaire
timeFrame: Baseline to six months.
measure: Echocardiogram (echo) Parameters
timeFrame: Baseline to six months.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References: