Study Stopped
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Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy
MUGA CRT
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2007
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 13, 2020
January 1, 2020
11 years
January 13, 2016
January 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to six months.
Secondary Outcomes (3)
Change in New York Heart Association (NYHA) class.
Baseline to six months.
Quality-of-Life Questionnaire
Baseline to six months.
Echocardiogram (echo) Parameters
Baseline to six months.
Study Arms (2)
Guided
EXPERIMENTALGuided LV lead placement for CRT.
Non-Guided
ACTIVE COMPARATORNon-guided LV lead placement for CRT.
Interventions
LV lead placement will be guided by left ventricular systolic function information from MUGA
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
February 1, 2016
Study Start
January 1, 2007
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
January 13, 2020
Record last verified: 2020-01