Symptomatic bradyarrhythmia Ventricular tachycardia Ventricular fibrillation Heart failure CHD ACHD, bradyarrhythmia, Ventricular tachycardia, Ventricular fibrillation
Conditions
Interventions
Three-dimensional (3D) mapping will be performed using the CARTO 3 System. The procedure will be conducted in accordance with standard electrophysiological study and device implantation techniques.
Af
Sponsors
Ishizu Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for inclusion: 1) Patients aged >=18 years at the time of obtaining informed consent 2) Patients with congenital heart disease (CHD) 3) Patients who meet at least one of the following criteria: (a) Patients with symptomatic bradyarrhythmia (e.g., sick sinus syndrome, advanced atrioventricular block, or complete atrioventricular block) for whom permanent pacemaker implantation is clinically indicated according to the Japanese Circulation Society (JCS) guidelines (b) Patients for whom implantation of an implantable cardioverter-defibrillator (ICD) for primary or secondary prevention is clinically indicated according to the JCS guidelines (c) Patients for whom cardiac resynchronisation therapy (CRT) with biventricular pacing is indicated according to the JCS guidelines 4) Patients who are able to attend follow-up visits in accordance with the study schedule 5) Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent based on their own free will, or via a legally authorised representative
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded: 1) Patients in whom insertion of a 3D mapping catheter is considered difficult 2) Patients who meet any contraindications specified in the instructions for use of the mapping catheter, including cases requiring manipulation within the same cardiac chamber as a prosthetic valve 3) Pregnant patients 4) Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success is defined as fulfillment of both of the following criteria (i) and (ii) at the end of the procedure: (i) Successful lead implantation at the pre-specified pacing target site. (ii) Pacing threshold, sensing amplitude, and impedance within clinically acceptable ranges | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the following: 1. Lead implantation site and measured values of pacing threshold, sensing amplitude, and impedance 2. Distance between the planned lead implantation site determined by mapping and the final lead position 3. Occurrence of device-related infection during the follow-up period 4. Occurrence of pacing failure or sensing failure during the follow-up period 5. Need for re-intervention during follow-up (e.g., lead revision or replacement) 6. Electrocardiographic findings (e.g., QRS duration) at baseline, the day after the procedure, and 3 months post-procedure 7. Changes in New York Heart Association (NYHA) functional class from baseline to 3 months post-procedure 8. Changes in echocardiographic parameters (systemic ventricular ejection fraction, stroke volume, cardiac output, cardiac index, and intraventricular dyssynchrony indices) from baseline to 3 months post-procedure 9. Changes in BNP levels from baseline to 3 months post-procedure | — |
Contacts
Public ContactMiyako Igarashi
University of Tsukuba Hospital
Outcome results
None listed