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Myocardial Fibrosis in Patients With Permanent Pacemakers

NCT05920226 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-04-11

No results posted yet for this study

Summary

Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right ventricle according to echocardiographic and electrocardiographic parameters, congestive heart failure progression, patients' quality of life and follow-up therapy of patients with identified myocardial fibrosis with existing pacemaker.

Study of changes in echocardiography, electrocardiography, myocardial fibrosis markers, the quality of life of patients will allow to choose the most optimal localization of the ventricular electrode during implantation of the permanent pacemakers system in order to improve the quality of life of the patients.

Conditions

Interventions

DEVICE

pacemakers implantation and assessment of cardiac function and cardiac fibrosis

150 patients will be implanted with pacemakers. In addition to the echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers, the tests described above will be repeated at 1 (V1), 12 (V2), 24 (V3) months after inclusion. Echocardiography and peripheral venous blood sampling for myocardial fibrosis markers detection will be repeated to all patients before pacemakers implantation and after 6,12 and 24 months of observation period. Contrast-enhanced cardiac magnetic resonance imaging (MRI) will be performed before pacemaker implantation and 6 months after surgery. In addition, pacemakers programming data will be evaluated after 1, 12, 24 months after inclusion in the study (atrioventricular delay, percentage of ventricular stimulation, episodes of high atrial frequency, fibrillation/atrial flutter, ventricular tachycardia).

DIAGNOSTIC_TEST

assessment of cardiac function and cardiac fibrosis

The patients who do not require a pacemaker placement will undergo diagnostic testing such as echocardiography, contrast-enhanced cardiac MRI and peripheral venous blood sampling for myocardial fibrosis markers.

Sponsors & Collaborators

  • Ryazan State Medical University

    lead OTHER

Principal Investigators

  • Igor Suchkov, MD DMedSc · Ryazan State Medical University

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2027-07-01
Completion
2028-07-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920226 on ClinicalTrials.gov