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| Name | Class |
|---|---|
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
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The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional stimulation | Active Comparator | An electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center. |
|
| Physiological stimulation | Active Comparator | Pacing the his-purkinje system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implantation and conventional cardiac pacing | Device | Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the incidence of pacemaker-induced heart disease | Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in end-systolic volume. | VTSVI | 12 Months |
| Correction of septal flash. | Correction of septal flash determined with echocardiography (M mode) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LluĂs Mont, MD, PhD | Contact | +34 93 2271778 | lmont@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Jose M Tolosana, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| LluĂs Mont, MD, PhD | Hospital Clinic of Barcelona | Study Director |
| Margarida Pujol Lopez, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Recruiting | Barcelona | 08036 | Spain |
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Randomized, unicentric, simple blind.
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The patient will be explained to be randomized to either one of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
| Conduction system pacing implant | Device | Right ventricular lead was placed to get his bundle or left bundle branch. |
|
| 12 Months |
| Incidence of new onset of atrial fibrillation. | 12 Months |
| Hospitalization due to heart failure. | Hospitalization: patient hospitalization (yes/no) | 12 Months |
| New York Heart Association functional classification. | Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | 12 Months |
| Pacing thresholds. | Pacing thresholds. | 12 Months |
| Total implantation and electrode implantation times. | Total implantation and electrode implantation times. | 12 Months |
| Adverse events. | Resulted in reintervention or the termination of significant device function | 12 Months |
| Six minute walking test. | Six minute walking test. | 12 Months |
| The Quality of Life Scale. | The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse). | 12 Months |
| NT-proBNP. | NT-proBNP measure | 12 Months |
| Hospital Clinic of Barcelona |
| Principal Investigator |