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

Prognostic Value of Cardiovascular Magnetic Resonance 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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmias
• Intervention / Treatment: Other: Cardiac Magnetic Resonance Imaging

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Xinqiao Lian; Phone Number: 18810639895; Email: lxq010126@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Contact: Xinqiao Lian; Phone Number: 18810639895; Email: lxq010126@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study population includes patients meeting indications for cardiac implantable electronic devices (CIEDs), encompassing those with indications for pacemakers, implantable cardioverter defibrillators, or cardiac resynchronization therapy. This cohort will include individuals with multiple underlying conditions such as heart failure, arrhythmias, or conduction disorders like left bundle branch block, which clinically necessitate the implantation of CIEDs.

Description

Inclusion Criteria:

1. Adult patients (≥18 years old).
2. Patients with guideline-based indications for cardiac implantable electronic device (CIED) therapy, including pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy.
3. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Implantable Electronic Device Cohort	Other: Cardiac Magnetic Resonance Imaging; Cardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite of sudden cardiac death (SCD) and SCD-equivalent events	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	1-10 years

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: CMR-CIED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No