Localization of CRT According to Echocardiography: LOCATE-Pilot Study

Status unconfirmed · Not applicable

Conditions studied: Heart Failure

In brief

Currently, the majority of heart failure patients who qualify for and receive a cardiac resynchronization therapy (CRT) device feel better than before their implant. However, there are some patients who do not improve after the implant. Michigan Heart is sponsoring a research study called LOCATE-Pilot to help understand whether the information from an echocardiogram, performed before implanting the CRT device, improves patients' responses to CRT. This is being done by evaluating your heart's function with an echocardiogram, to measure your heart's response during therapy. The study hypothesis is that response to CRT may be optimized by guiding left ventricular lead placement to the maximally delayed, viable basal segment of the left ventricle.

Key facts

Study ID

NCT00234611

Run by

Michigan Heart, PC

People needed

60

Starts

2005-09-01

Expected to finish

2007-04-01

Last updated by the study team

2006-11-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male/female patients
• NYHA class III and IV chronic heart failure
• symptoms refractory to standard therapy (beta blocker and either ACE-I or ARB on stable dosages for 1 month minimum and duration of 3 months therapy minimum)
• patient has signed and dated informed consent
• patient able to receive pectoral device implant
• QRS>= 130 ms
• EF <= 35%
• follow-up at Michigan Heart CHF clinic feasible
• patient understanding of protocol and willing to comply

You may not qualify if…

• recent myocardial infarction (<3 months)
• recent surgical or percutaneous revascularization (<3months)
• age < 18 months
• permanent AF without AV junction ablation
• life expectancy under 6 months
• women of child-bearing potential and not willing or able to take birth control
• mechanical tricuspid valve
• prior orthotopic heart transplantation
• intermittent inotropic therapy or inotropic-dependent

Where it is running

• Michigan Heart, PC — Ypsilanti, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.