Status:
COMPLETED
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with...
Detailed Description
This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac...
Eligibility Criteria
Inclusion
- Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
- Have a stable pharmacological therapy.
Exclusion
- Have a contra-indication to general anesthesia;
- Have a scheduled cardiac surgery;
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
- Have a life expectancy of less than 6 months;
- Are unable to provide informed consent;
- Are unable to comply with the follow-up schedule and tests;
- Are minor (age below 18 years);
- Are pregnant or are planning for pregnancy in the next 6 months.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00819117
Start Date
November 1 2007
End Date
October 1 2009
Last Update
February 4 2019
Active Locations (2)
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1
Ospedale Cisanello
Pisa, Italy, 56126
2
Azienda Sanitaria Osperaliera Ordine Mauriziano
Torino, Italy, 10128