Ventricular tachycardia, ventricular fibrillation.
Conditions
Interventions
Defibrillation test during implantation, chest-CT tomography for an evaluation of the lead position after the implantation.
Sponsors
Nagoya University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients at participating institutions who underwent transvenous implantation of an ICD or CRT-D (cardiac resynchronization therapy defibrillator) using the Abbott Durata ICD lead between January 2020 and the date of study approval, and who either have a prior history of chest CT imaging or newly provided informed consent for additional CT imaging at the time of data access after study approval (retrospective cohort). - Patients at participating institutions who will undergo ICD or CRT-D implantation using the Abbott Durata ICD lead and have provided informed consent for CT imaging (prospective cohort). - Newly implanted device cases. - Patients aged 18 years or older, regardless of sex. - The type of ICD lead shall be limited to active-fixation (screw-in) leads. - Patients who have provided written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: - Patients who did not provide informed consent to participate in this study. - Cases in which a tined lead was used. - Cases in which the implanted ICD lead was not an Abbott Durata ICD lead. - Patients with a previous history of defibrillation lead implantation, in whom the lead was extracted and subsequently reimplanted. - Upgrade cases from a conventional pacemaker system. - Cases in which a subcutaneous defibrillation lead system was used. - In the retrospective cohort, cases without prior CT imaging or without additional consent for new CT imaging. - Cases in which the Abbott Durata ICD lead was used, but the ICD or CRT-D pulse generator was manufactured by another company. - Any other cases deemed inappropriate for inclusion in the study at the discretion of the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of true septal ICD lead implantation based on an imaging modality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lead parameters (threshold, sensing, and impedance) at six months postoperatively, shock impedance, defibrillation threshold, paced QRS duration, incidence of lead-related complications, antitachycardia pacing and defibrillation success rates for ventricular arrhythmias, occurrence of atrial fibrillation, and all-cause mortality and heart failure hospitalization during two years after implantation. | — |
Countries
Japan
Contacts
Public ContactSatoshi Yanagisawa
Nagoya University Graduate School of Medicine Department of Advanced Cardiovascular Therapeutics
Outcome results
None listed