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| Name | Class |
|---|---|
| Fundació La Marató de TV3 | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
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Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deep | Experimental | The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration <=140ms. |
|
| Apex | Active Comparator | The ventricular lead will be placed in the right ventricular apex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implant | Device | All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead. |
| Measure | Description | Time Frame |
|---|---|---|
| Pacing-induced cardiomyopathy | Decrease in the left ventricular ejection fraction (LVEF) by >10% as compared to the LVEF before pacemaker implant and final LVEF<45%. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| LVEF during follow-up | To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups. | 12 months |
| Mitral and tricuspid regurgitation |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications related to the ventricular lead | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Di Marco, MD, PhD | Contact | +34932 60 75 00 | 8385 | adimarco@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Di Marco, MD, PhD | IDIBELL and Hospital Universitario de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebrón | Not yet recruiting | Barcelona | Spain |
The study protocol and the informed consent form will be available upon request during the whole duration of the study.
During the whole duration of the study
Request to the principal investigator.
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To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.
| 12 months |
| New York Heart Association (NYHA) class | To compare the NYHA class one year after pacemaker implant in the two groups. | 12 months |
| Brain Natriuretic Peptide levels | To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups. | 12 months |
| heart failure | Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy. | 12 months |
| Hospital General Universitario de Castellón | Not yet recruiting | Castellon | Spain |
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| Hospital Virgen de las Nieves | Not yet recruiting | Granada | Spain |
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| Hospital Universitario de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Spain |
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| Hospital La Fe | Not yet recruiting | Valencia | Spain |
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| Hospital Lozano Blesa | Not yet recruiting | Zaragoza | Spain |
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