Conduction System Pacing Clinical Trial
— PHYSPAVBOfficial title:
Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Institut d'Investigacions Biomèdiques August Pi i Sunyer |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Change in end-systolic volume. | VTSVI | 12 Months | |
Secondary | Correction of septal flash. | Correction of septal flash determined with echocardiography (M mode) | 12 Months | |
Secondary | Incidence of new onset of atrial fibrillation. | 12 Months | ||
Secondary | Hospitalization due to heart failure. | Hospitalization: patient hospitalization (yes/no) | 12 Months | |
Secondary | 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 | |
Secondary | Pacing thresholds. | Pacing thresholds. | 12 Months | |
Secondary | Total implantation and electrode implantation times. | Total implantation and electrode implantation times. | 12 Months | |
Secondary | Adverse events. | Resulted in reintervention or the termination of significant device function | 12 Months | |
Secondary | Six minute walking test. | Six minute walking test. | 12 Months | |
Secondary | 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 | |
Secondary | NT-proBNP. | NT-proBNP measure | 12 Months |
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