None listed
Conditions
Interventions
Procedure/Surgery : ICD-CSP group:
Using a specialized sheath (Model C315-HIS Delivery Catheter, Medtronic Inc.), a bipolar pacing lead (SelectSecure MRI 3830) is progressively screwed into the ventri
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Indications for Implantable Cardioverter Defibrillator (ICD) Therapy Age Range: Between 19 and 79 years old ICD Therapy Indication: Primary Prevention: For patients at high risk of sudden cardiac death (SCD) but without a prior history of life-threatening arrhythmias. Secondary Prevention: For patients who have survived a cardiac arrest due to ventricular tachycardia (VT) or ventricular fibrillation (VF), or have experienced spontaneous sustained VT causing syncope or significant hemodynamic compromise. Thoracic Key Heart Failure with Reduced Ejection Fraction (HFrEF): Left ventricular ejection fraction (LVEF) =35%. Heart failure symptoms (New York Heart Association [NYHA] functional class II–IV). Presence of structural heart disease. ICD therapy is indicated for both primary and secondary prevention in this population. NCBI Atrioventricular (AV) Conduction Delay: PR interval >200 milliseconds. This may indicate advanced AV block, potentially necessitating pacing therapy. QRS Duration: QRS duration <130 milliseconds. In the context of a QRS duration <150 milliseconds with a non-left bundle branch block (non-LBBB) morphology, ICD therapy may still be considered, especially if there are other risk factors for arrhythmias.
Exclusion criteria
Exclusion criteria: Contraindications for Implantable Cardioverter Defibrillator (ICD) Therapy Patients with a history of persistent or permanent atrial fibrillation (AF) Atrial fibrillation, especially when persistent or permanent, can complicate the management of ICD therapy due to the potential for rapid ventricular rates and the challenges in distinguishing between atrial and ventricular arrhythmias. Second-degree atrioventricular (AV) block or complete AV block These conduction abnormalities can interfere with the proper functioning of the ICD, particularly in terms of pacing and arrhythmia detection. Patients with a history of implantable cardiac devices Prior implantation of devices such as pacemakers or other ICDs may influence the decision for a new ICD implantation, considering factors like lead integrity and infection risk. Patients with mechanical tricuspid valve prostheses The presence of a mechanical valve may pose surgical challenges and increase the risk of complications during ICD implantation. Patients with a history of ventricular septal defect surgery or myocardial infarction (MI) with ventricular septal involvement Structural heart changes from these conditions can affect the heart's electrical system, potentially complicating ICD therapy. Patients with end-stage renal disease (ESRD) The presence of ESRD can complicate the management of ICD therapy due to issues like electrolyte imbalances and the need for dialysis. Patients with channelopathies Inherited arrhythmia syndromes can present unique challenges in ICD therapy, requiring careful consideration of the underlying genetic condition. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception during the clinical trial period The safety of ICD implantation during pregnancy or breastfeeding is not well-established, and the potential risks to the fetus or infant must be carefully weighed. Patients with a history of heart transplantation Heart transplant recipients typically do not benefit from ICDs due to the denervation of the heart, which affects arrhythmia detection and therapy. Patients with a life expectancy of less than one year due to other medical conditions In such cases, the risks of ICD implantation may outweigh the potential benefits. Patients participating in other interventional studies involving intracardiac devices Participation in multiple studies may introduce variables that complicate the assessment of ICD therapy outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Scores obtained before the procedure will be compared with those at 6 months and 1 year after the procedure during follow-up through the first year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment will include left ventricular dimensions (end-diastolic and end-systolic) and left atrial volume index (LAVI) measured by echocardiography, as well as physical activity, AV synchrony, arrhythmia episodes, and atrial fibrillation burden (%) obtained from device log records. The number of patients who undergo upgrade to CRT will also be evaluated. | — |
Countries
Korea, Republic of
Contacts
Public ContactJUN KIM
Asan Medical Center
Outcome results
None listed