Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07336225

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old).
  • Patients with guideline-based indications for cardiac implantable electronic device (CIED) therapy, including pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy.
  • Patients who underwent cardiovascular magnetic resonance (CMR) imaging as part of routine clinical evaluation prior to CIED implantation or consideration of CIED therapy.

Exclusion criteria

  • Patients younger than 18 years of age.
  • Patients with non-diagnostic or poor-quality CMR images that preclude reliable image analysis.
  • Patients with incomplete key clinical data or missing follow-up information for primary outcome assessment.
  • Patients with prior heart transplantation or implantation of ventricular assist devices before CMR examination.
  • Patients with congenital heart disease requiring surgical correction.

Treatment and study plan

Cardiac Magnetic Resonance Imaging

Other

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

Primary outcomes

  1. A composite of sudden cardiac death (SCD) and SCD-equivalent events

    Time frame: 1-10 years

    SCD, defined as unexpected death within ≤1 hour of cardiac symptoms in the absence of any progressive cardiac deterioration, during sleep, or ≤24 hours of last being seen alive. SCD-equivalent events, defined as an appropriate implantable cardioverter defibrillator shock for ventricular arrhythmia, a nonfatal episode of ventricular fibrillation or spontaneous sustained ventricular tachycardia causing hemodynamic compromise and requiring cardioversion

Study contacts

Contact information is provided by the study sponsor or research team.

Xinqiao Lian

CONTACT

[email protected]

18810639895

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2035
Study completion
2040
First posted
Jan 13, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.