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RecruitingNCT07336225Updated Jan 27, 2026

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

An observational study in Arrhythmias, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

From the registry’s dates

  • Started Jan 2010; still recruiting 16 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Arrhythmias

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03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cardiac Implantable Electronic Device Cohort

    Other: Cardiac Magnetic Resonance Imaging

Interventions

  • OtherCardiac 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1-10 years

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Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07336225
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible party
Minjie Lu (Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Jan 13, 2026
Start date
Jan 1, 2010
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2040 (estimated)
Last update
Jan 27, 2026

Study contacts

Xinqiao Lian
Contact
lxq010126@163.com
18810639895

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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