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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date January 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Guided
LV lead placement will be guided by left ventricular systolic function information from MUGA
Non-guided
LV lead placement will be conventional posterolateral placement

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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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