Conduction System Pacing, Conventional Ventricular Pacing
Conditions
Keywords
Pacemaker-induced cardiomyopathy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPacemaker implantation and conventional cardiac pacing
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.
DEVICEConduction system pacing implant
Right ventricular lead was placed to get his bundle or left bundle branch.
Sponsors
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Randomized, unicentric, simple blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* The patient must be ≥ 18 years of age. * The patient must indicate their acceptance to participate in the study by signing an informed consent document. * Patients with EF\> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
Exclusion criteria
* Inability to understand and sign the informed consent. * Patients with severe comorbidities and life expectancy \<1 year. * Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life. * Patients who cannot come to our center to carry out the follow-up of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the incidence of pacemaker-induced heart disease | 12 months | Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF \<45% or admission due to heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in end-systolic volume. | 12 Months | VTSVI |
| Correction of septal flash. | 12 Months | Correction of septal flash determined with echocardiography (M mode) |
| Incidence of new onset of atrial fibrillation. | 12 Months | — |
| Hospitalization due to heart failure. | 12 Months | Hospitalization: patient hospitalization (yes/no) |
| New York Heart Association functional classification. | 12 Months | 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. |
| Pacing thresholds. | 12 Months | Pacing thresholds. |
| Total implantation and electrode implantation times. | 12 Months | Total implantation and electrode implantation times. |
| Adverse events. | 12 Months | Resulted in reintervention or the termination of significant device function |
| Six minute walking test. | 12 Months | Six minute walking test. |
| The Quality of Life Scale. | 12 Months | 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). |
| NT-proBNP. | 12 Months | NT-proBNP measure |
Countries
Spain
Contacts
CONTACTLluís Mont, MD, PhD
PRINCIPAL_INVESTIGATORJose M Tolosana, MD, PhD
Hospital Clinic of Barcelona
STUDY_DIRECTORLluís Mont, MD, PhD
Hospital Clinic of Barcelona
PRINCIPAL_INVESTIGATORMargarida Pujol Lopez, MD
Hospital Clinic of Barcelona
Outcome results
None listed