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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvenous Lead (TVN CRT) | Active Comparator | Control group: resynchronization via a transvenous left ventricular lead (TVN CRT) |
|
| Epicardial Lead (EPI CRT) | Experimental | Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy implant | Device | Device implant with appropriate leads |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Grazia Bongiorni, MD | Ospedale Cisanello, Pisa, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Cisanello | Pisa | 56126 | Italy | |||
| Azienda Sanitaria Osperaliera Ordine Mauriziano |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Torino |
| 10128 |
| Italy |