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This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL -CRT study is designed to test the hypothesis that, in patients with atrioventricular block of I degree and standard pacing indications , biventricular pacing is superior to single stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing , as assessed by echocardiography an endpoint defined in terms of maintenance over time of left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV ) .
Clinical data suggest that biventricular pacing is able to preserve the myocardial performance more effectively than the right ventricular pacing in patients with atrioventricular block and mild systolic dysfunction . In particular, some studies have shown that medical therapy in these patients could be responsible for an increase in the cumulative percentage of chronic pacing over the 40% threshold , the threshold associated with a higher incidence of atrial fibrillation and hospitalization for heart failure and ventricular arrhythmias . In addition , patients with pre-existing left ventricular dysfunction and indication for pacing standards have improved left ventricular systolic function , exercise capacity and quality of life as a result of biventricular pacing as compared with Right ventricular pacing . These results suggest that biventricular pacing is a feasible option for permanent pacing in patients who have normal systolic function of the left ventricle and that this can be altered from the adverse effects of conventional Right ventricular pacing on systolic function of the left ventricle . This reality has prompted physicians to assess the value and role of cardiac resynchronization therapy (CRT ) in patients with prolonged Atrio-Ventricular (AV) conduction . Note the deleterious effects of chronic stimulation of the right ventricle , the optimal pacing mode should always be considered in these patients at the time of implantation . This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction, by comparing it with the treatment with dual chamber device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right ventricular stimulation | Active Comparator | patients with conventional Right Ventricular Stimulation (only RV) with optimized algorithms for minimization of pacing |
|
| Biventricular Stimulation | Experimental | Patients with biventricular stimulation (Right Ventricle and Left Ventricle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac resynchronization therapy pacemaker | Device | biventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p) |
|
| Measure | Description | Time Frame |
|---|---|---|
| LVEF | LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle) | 2 years |
| LVESV | LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| echocardiographic left ventricular measures | . Structure and cardiac function:
| 2 years |
| Echocardiographic altrial measures |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Botto | S. Anna Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Sant'Anna | Recruiting | Como | Como | 22100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31722381 | Derived | Botto GL, Iuliano A, Occhetta E, Belotti G, Russo G, Campari M, Valsecchi S, Stabile G. A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study. Europace. 2020 Feb 1;22(2):299-305. doi: 10.1093/europace/euz321. |
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| Dual chamber pacemaker | Device | right ventricular stimulation with dual chamber pacemaker |
|
Size of the left atrium (diameter and volume)
| 2 years |
| Clinical outcome | Clinical benefit:
| 2 years |
| Atrial fibrillation (AF) | Incidence of AF:
| 2 years |