Heart MRI to predict outcomes for people getting pacemakers or defibrillators

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

This study will try to see if detailed heart MRI scans done before device implantation can predict sudden cardiac death or similar events in adults receiving pacemakers, ICDs, or CRT.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07336225 on ClinicalTrials.gov

What this trial studies

This is an observational cohort of adult patients who had cardiovascular magnetic resonance (CMR) imaging before consideration or implantation of a cardiac implantable electronic device (pacemaker, ICD, or CRT). Investigators will extract multiparametric CMR markers — including structural and functional indices, myocardial strain, late gadolinium enhancement, entropy, and T1/T2 mapping — from preoperative scans. Long-term clinical outcomes, with a primary endpoint of sudden cardiac death or SCD-equivalent events, will be obtained from medical records and follow-up. The goal is to determine whether these imaging markers predict adverse arrhythmic events in real-world CIED candidates.

Who should consider this trial

Good fit: Adults (age 18 or older) with guideline-based indications for a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy who had preoperative CMR of diagnostic quality and available follow-up data are ideal candidates.

Not a fit: Patients with non-diagnostic or poor-quality CMR images, missing key clinical or follow-up data, prior heart transplant or ventricular assist device, or surgically corrected congenital heart disease are unlikely to benefit from inclusion in this analysis.

Why it matters

Potential benefit: If successful, the approach could help clinicians better identify which device candidates are at highest risk of sudden cardiac death and tailor therapy accordingly.

How similar studies have performed: Prior research has linked CMR markers such as late gadolinium enhancement and strain to arrhythmic risk, but applying a multiparametric CMR prognostic model specifically in CIED candidates is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xinqiao Lian

Conditions Arrhythmias