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The goal of this randomized, multicenter prospective study is to demonstrate that the activation of biventricular pacing with fusion and AV optimization feature will increase the rate of CRT responders in terms of LV reverse remodeling, compared with conventional biventricular pacing.
Treatment of HFrEF with CRT. CRT is an established guideline-recommended treatment for patients who are refractory to optimized pharmacologic therapy, and have reduced ejection fraction and increased QRS duration. It works by restoring atrioventricular, inter- and intra-ventricular synchrony and in so doing, it has been shown to improve symptoms, LV systolic function and survival. Nevertheless, a significant proportion of patients (30-45%) do not benefit after CRT and are considered non-respondent. Non-response to CRT is multifactorial (poor substrate to resynchronize, difficulty in the implant, age, gender, aetiology, and/or comorbidities). Recently, other negative determinants have been identified as cause of non-responding to CRT such as the lack of fusion of ventricular contraction with the intrinsic right ventricular conduction and non-optimal AV delay programming which, in turn, is related to the duration of PR interval. Another possible reason for non-responding to CRT is a non-optimal LV pacing site.
The CRUSTY PLUS trial is aimed to establish the relevance for the success of CRT of these three factors: lack of fusion, non-optimized A-V conduction, and LV pacing site by comparing the response to CRT with a standard BIV device with fixed out-of-the-box A-V delay with that to a BIV device (Sync A-V plus) endowed with an algorithm which is continuously measuring the patients' A-V conduction and is able to adjust the stimulation parameters according to the measured PR interval, achieving a more dynamic A-V interval and allowing a perfect fusion of ventricular contraction. The algorithm is also able to optimize LV intraventricular synchrony. Sync A-V plus is endowed with a quadripolar multipoint pacing (MPP) CRT-D system allowing pacing of the LV with 2 vectors. This methodology allows a simultaneous earlier and wider excitation of ventricular tissue resulting in better synchronization and better cardiac output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyncAV plus group | Experimental | Patients implanted with a CRT-D programmed with SyncAV plus function ON. |
|
| Biv Trad | No Intervention | Patients implanted with a CRT-D programmed with fixed AV delay. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyncAV function on | Device | CRT-D with SyncAV plus activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in left ventricular end systolic volume (LVESV) between baseline and 6 months | The primary endpoint is response to CRT defined as > 15% relative reduction in Left Ventricular End Systolic Volume (LVESV) at 6 months after implantation, evaluated by Echocardiography | Month 6 |
| Reduction in QRS duration after randomization | The primary endpoint is the reduction of QRS duration compared to the intrinsic QRS. Defined as > 13% relative reduction in QRS duration compared with the intrinsic QRS, evaluated by ECG.Defined as > 13% relative reduction in QRS duration compared with the intrinsic QRS, evaluated by ECG. | within 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of CRT Responders at 12 months after MPP activation programmed after the 6 Months follow-up. | Percentage of non-responders at 6 Months responders at 12 Months with MPP | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion / Exclusion criteria: Inclusion criteria: To participate in this clinical study, patients must meet ALL of the following inclusion criteria:
Exclusion criteria: Patients who meet any of the following exclusion criteria are NOT eligible to participate in the clinical study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Rapacciuolo, Prof | Contact | 0817462235 | antonio.rapacciuolo@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Jaume Francisco Pascual, Dr | Hospital Vall d'Hebron | Study Chair |
| Nuria Rivas Gandara, Dr | Hospital Vall d'Hebron | Study Chair |
| Angelo Auricchio, Prof |
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Randomized study with 2 groups: control group (Traditional biventricular stimulation), study group (biventricular stimulation + SyncAV feature)
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| Istituto Cardiocentro Ticino |
| Study Chair |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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