CMR-Based Prognostic Study in Patients With Cardiac Impla... | NCT07336225

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

NCT07336225

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Recruiting

Last Update Posted

Jan 27, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Arrhythmias

Interventions

Cardiac Magnetic Resonance Imaging

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2035Estimated

Completion Date

Dec 31, 2040Estimated

First Submitted Date

Jan 3, 2026

First Submission Date that Met QC Criteria

Jan 3, 2026

First Posted Date

Jan 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2026

Last Update Posted Date

Jan 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Implantable Electronic Device Cohort			Other: Cardiac Magnetic Resonance Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Xinqiao Lian	Contact	18810639895		lxq010126@163.com

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided