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

NCT ID: NCT02669290

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Heart Failure; Left Ventricular Dysfunction; Cardiac Resynchronization Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guided

Guided LV lead placement for CRT.

Group Type: EXPERIMENTAL

Guided

Intervention Type: OTHER

LV lead placement will be guided by left ventricular systolic function information from MUGA

Non-Guided

Non-guided LV lead placement for CRT.

Group Type: ACTIVE_COMPARATOR

Non-guided

Intervention Type: OTHER

LV lead placement will be conventional posterolateral placement

Interventions

Guided

LV lead placement will be guided by left ventricular systolic function information from MUGA

Intervention Type: OTHER

Non-guided

LV lead placement will be conventional posterolateral placement

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

10-04791

Identifier Type: -

Identifier Source: org_study_id