Status:
UNKNOWN
Localization of CRT According to Echocardiography: LOCATE-Pilot Study
Lead Sponsor:
Michigan Heart, PC
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 w...
Detailed Description
CRT is a promising treatment modality for medically-refractory New York Heart Association (NYHA) class III or IV heart failure (HF) patients with intraventricular conduction delay (QRS \> 130 ms). The...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00234611
Start Date
September 1 2005
End Date
April 1 2007
Last Update
November 6 2006
Active Locations (1)
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1
Michigan Heart, PC
Ypsilanti, Michigan, United States, 48197