Not_yet_recruitingNCT07322900

Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing Cardiac Implantable Electronic Device (CIED) Implantation Using an Artificial Intelligence-Based Clinical Decision (AID) Support System

Sponsor: Istanbul University - Cerrahpasa

Trial Details

ConditionPain Measurement, Chronic Pain, Cardiac Implantable Electrical Devices, Neuropathic Pain, Chronic Post Surgical Pain
StatusNot_yet_recruiting
Participants180
Est. Completion1 Dec 2026
Last Updated5 May 2026

Primary Outcome

Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments; Incidence of Chronic Postsurgical Pain (CPSP) Based on DN-4 Assessments; Incidence of Chronic Postsurgical Pain (CPSP) Based on Pressure Pain Threshold Assessments

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Adults aged ≥18 years. * Patients who have undergone first-time implantation of a cardiac implantable electronic device (CIED), including pacemaker (PM), implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT). * Device implantation performed within the past 12 months at Istanbul University-Cerrahpaşa Cardiology Institute. * Ability to attend scheduled follow-up visits at 3, 6, and 12 months post-implantation. * Ability to understand study procedures and provide written informed consent. Exclusion Criteria: * History of neuropathic or chronic pain syndromes prior to implantation (e.g., fibromyalgia, diabetic neuropathy). * Presence of neurodegenerative, autoimmune, or vascular disorders affecting peripheral or central pain pathways. * Known malignancy, active infection, or recent trauma in the chest or upper extremities. * Prior CIED replacement or battery exchange procedures. * Use of chronic analgesic or neuropathic pain medications (e.g., opioids, gabapentinoids, antidepressants) for conditions unrelated to the procedure. * Cognitive impairment or psychiatric disorders that may interfere with study participation or reliable pain assessment. * Inability to comply with follow-up or withdrawal of consent at any time.

View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service