Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy (MUGA CRT)
Primary Purpose
Heart Failure, Left Ventricular Dysfunction, Cardiac Resynchronization Therapy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided
Non-guided
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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)
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Guided
Non-Guided
Arm Description
Guided LV lead placement for CRT.
Non-guided LV lead placement for CRT.
Outcomes
Primary Outcome Measures
Six minute walk test (6MWT)
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Secondary Outcome Measures
Change in New York Heart Association (NYHA) class.
Clinicians classify patients' heart failure according to the severity of their symptoms.
Quality-of-Life Questionnaire
Minnesota Living with Heart Failure Questionnaire: To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired.
Echocardiogram (echo) Parameters
Echo is a type of ultrasound test that takes pictures of the heart. These pictures will be used to assess whether there are any improvements in left ventricular function.
Full Information
NCT ID
NCT02669290
First Posted
January 13, 2016
Last Updated
January 9, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02669290
Brief Title
Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy
Acronym
MUGA CRT
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Ventricular Dysfunction, Cardiac Resynchronization Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided
Arm Type
Experimental
Arm Description
Guided LV lead placement for CRT.
Arm Title
Non-Guided
Arm Type
Active Comparator
Arm Description
Non-guided LV lead placement for CRT.
Intervention Type
Other
Intervention Name(s)
Guided
Intervention Description
LV lead placement will be guided by left ventricular systolic function information from MUGA
Intervention Type
Other
Intervention Name(s)
Non-guided
Intervention Description
LV lead placement will be conventional posterolateral placement
Primary Outcome Measure Information:
Title
Six minute walk test (6MWT)
Description
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time Frame
Baseline to six months.
Secondary Outcome Measure Information:
Title
Change in New York Heart Association (NYHA) class.
Description
Clinicians classify patients' heart failure according to the severity of their symptoms.
Time Frame
Baseline to six months.
Title
Quality-of-Life Questionnaire
Description
Minnesota Living with Heart Failure Questionnaire: To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired.
Time Frame
Baseline to six months.
Title
Echocardiogram (echo) Parameters
Description
Echo is a type of ultrasound test that takes pictures of the heart. These pictures will be used to assess whether there are any improvements in left ventricular function.
Time Frame
Baseline to six months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy
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