Heart Failure Clinical Trial
— MUGA CRTOfficial title:
Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy (MUGA-CRT)
NCT number | NCT02669290 |
Other study ID # | 10-04791 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2007 |
Est. completion date | January 2018 |
Verified date | January 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 60 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in New York Heart Association (NYHA) class. | Clinicians classify patients' heart failure according to the severity of their symptoms. | Baseline to six months. | |
Secondary | 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. | Baseline to six months. | |
Secondary | 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. | Baseline to six months. |
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