Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique

Study Overview
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Brief Summary
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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
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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.

Official Title
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INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Cardiac Resynchronization Therapy implant


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvenous Lead (TVN CRT)<br>Control group: resynchronization via a transvenous left ventricular lead (TVN CRT) | Device: Cardiac Resynchronization Therapy implant<br>* Device implant with appropriate leads<br>|
| Experimental: Epicardial Lead (EPI CRT)<br>Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT) | Device: Cardiac Resynchronization Therapy implant<br>* Device implant with appropriate leads<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicardial leads, Cardiac Resynchronization Therapy