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Data-Driven and Digital-Twin–Integrated Decision Support for Cardiac Electrophysiology and Coronary Interventions

Data-Driven and Digital-Twin–Integrated Decision Support for Cardiac Electrophysiology and Coronary Interventions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110274
Enrollment
Unknown
Registered
2025-10-11
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Intervention in the Exposure Group (Intelligent Decision-Support Group):None
Intervention in the Non-Exposure Group (Control Group):None

Sponsors

The First Hospital of Handan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria Separate enrollment criteria will be defined for the cardiac electrophysiology (EP) and percutaneous coronary intervention (PCI) populations. Individuals meeting the following conditions may be included: 1.General criteria: Age 18–85 years; no sex restriction. Able to understand the study content and capable of completing follow-up as required. 2.EP cohort–specific criteria: Diagnosed arrhythmia and scheduled to undergo electrophysiology interventional therapy such as catheter ablation, including patients with clear indications such as atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia. 3.Retrospective cohort: patients who have undergone the above treatments in recent years. Prospective cohort: patients who will receive ablation therapy at this hospital and who have signed informed consent. PCI cohort–specific criteria: Diagnosed coronary artery disease and receiving percutaneous coronary intervention (PCI), including patients with indications such as stable angina, unstable angina, or non–ST-segment elevation myocardial infarction (NSTEMI). Retrospective cohort: patients who have previously undergone PCI. Prospective cohort: patients who will undergo elective or emergency PCI at this hospital and who have signed informed consent. 4.Data requirements: Clinical data are relatively complete. To build the digital twin model: EP patients are required to have preoperative cardiac imaging (e.g., cardiac MRI, CT, or echocardiography) and relevant electrophysiology test results; PCI patients are required to have coronary angiography or coronary CTA available for analysis. If additional examinations are needed during the prospective stage (e.g., pre-ablation MRI for scar assessment, or pre-PCI CTA-derived FFR), patients agree to undergo the relevant examinations.

Exclusion criteria

Exclusion criteria: 1. Presence of severe systemic diseases (e.g., advanced malignancy, active infection, severe hepatic or renal insufficiency) with an expected survival shorter than the follow-up period. 2. Severe psychiatric or cognitive disorders that make the individual unable to comply with study follow-up. 3. Pregnant or lactating women (in light of X-ray examinations and other considerations, exclusion may be decided based on specific circumstances). 4. Prior interventional therapy but lacking key preoperative examinations or with perioperative data unavailable (mainly addressing data completeness requirements for retrospective cases). 5. In prospective recruitment, refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
12-month incidence of major adverse events;Major Adverse Cardiac Events;

Secondary

MeasureTime frame
Number of stents implanted;Acute procedural success rate;Immediate angiographic success rate;Procedure duration;Procedure duration;Fluoroscopy time;Contrast volume;Number of ablations;

Countries

China

Contacts

Public ContactMiao Mengdan

The First Hospital of Handan

m18032936267@163.com+86 180 3293 6267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026