Myocardial Fibrosis in Patients With Permanent Pacemakers

Active, not recruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2028

Conditions
FibrosisAtrial FibrillationAtrial Flutter
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.

Trial Locations (1)

390026

Ryazan State Medical University, Ryazan

All Listed Sponsors
lead

Ryazan State Medical University

OTHER