Heart Failure
Conditions
Keywords
Epicardial leads, Cardiac Resynchronization Therapy
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 a CRT device.
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 resynchronization therapy. After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups: * Control group: resynchronization via a transvenous left ventricular lead (TVN CRT); * Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT). All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads. Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.
Interventions
DEVICECardiac Resynchronization Therapy implant
Device implant with appropriate leads
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have an approved indication for implantation of an CRT device (ESC guidelines , including any update); * Have a stable pharmacological therapy.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups. | 6 months follow up after implant |
Countries
Italy
Outcome results
None listed