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RecruitingNCT07336225

CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices

Prognostic Value of Cardiovascular Magnetic Resonance in Patients With Cardiac Implantable Electronic Devices

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,500 (estimated)
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Cardiac implantable electronic devices (CIEDs) are widely used to treat patients with heart failure, malignant arrhythmias, and other conditions. However, accurately identifying suitable candidates for CIED implantation remains a clinical challenge. Cardiovascular magnetic resonance imaging (CMR) provides a comprehensive assessment of cardiac structure, function, and tissue characteristics, facilitating evaluation of the myocardial substrate for arrhythmias. This study aims to evaluate the prognostic value of multiparametric CMR-derived imaging markers in CIED patients through preoperative CMR examinations. Imaging parameters of interest include structural-functional indices, myocardial strain, late gadolinium enhancement, entropy, and T1 and T2 mapping. Long-term clinical outcomes will be obtained from existing medical records and follow-up. The primary endpoint is sudden cardiac death (SCD) or SCD-equivalent events, defined as SCD, resuscitated cardiac arrest, sustained ventricular tachycardia or ventricular fibrillation, or appropriate ICD therapy. Secondary endpoints include all-cause mortality or heart failure rehospitalization. This study aims to elucidate the role of CMR in assessing CIED treatment indications and long-term risk stratification, thereby helping to optimize CIED implantation decisions.

Conditions

Interventions

TypeNameDescription
OTHERCardiac Magnetic Resonance ImagingCardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management.

Timeline

Start date
2010-01-01
Primary completion
2035-12-31
Completion
2040-12-31
First posted
2026-01-13
Last updated
2026-01-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07336225. Inclusion in this directory is not an endorsement.