I46.9
Conditions
Interventions
Group 1: Patients without an ICD before planned pulmonary valve replacement
Patients without an implanted defibrillator who are scheduled for pulmonary valve replacement undergo cardiac MRI-based risk
Sponsors
Deutsches Herzzentrum der Charité
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Adult patients up to 75 years of age - Patients with cyanotic congenital heart disease after surgical reconstruction of the ventricular outflow tract - Inclusion irrespective of sex, origin, ICD status or comorbidities
Exclusion criteria
Exclusion criteria: - Lack of independent informed consent - Life expectancy < 1 year - Patients with previous surgical procedures involving a large incision or structural damage to the ventricular myocardium - Contraindications to electrophysiological examination, e.g. mechanical tricuspid valve replacement - Contraindications to MRI examination - Expected insufficient MRI image quality, except for patients in the ICD study group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the 24-month incidence of a composite clinical endpoint consisting of haemodynamically relevant ventricular tachycardia, implantation of an implantable cardioverter-defibrillator (ICD), and ICD-related complications. ICD-related complications include, but are not limited to, appropriate or inappropriate ICD therapies, lead-related complications, device infections, and ICD-related events requiring intervention or revision. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to first haemodynamically relevant ventricular tachycardia. - Incidence of ventricular tachycardia during follow-up. - Time to first appropriate ICD therapy, defined as antitachycardia pacing or ICD shock. - Rate of appropriate ICD therapies per person-year. - Rate of inappropriate ICD therapies. - Cumulative incidence of ICD implantation during follow-up. - Frequency of ICD-related complications, including lead-related complications, infections, inappropriate shocks, and events requiring revision or re-intervention. - Detection and longitudinal assessment of slowly conducting anatomical isthmuses or ventricular tachycardia-associated substrates by cardiac MRI and/or electroanatomical mapping. - Diagnostic and prognostic performance of cardiac MRI for identifying patients at increased risk of ventricular tachycardia, assessed by sensitivity, specificity, positive and negative predictive value, and AUC/c-index. - Safety of the combined risk stratification approach, including cardiac MRI, electroanatomical mapping, and, if indicated, substrate-based catheter ablation, assessed by the frequency of serious adverse events and procedural complications. - Changes in risk classification and clinical therapeutic decision-making, particularly regarding the indication for ICD implantation or catheter ablation. - Long-term occurrence of clinical events over the complete follow-up period of up to five years. | — |
Countries
Germany
Contacts
Public ContactKatja Zeppenfeld
Deutsches Herzzentrum der Charité
Outcome results
None listed