About this trial
This multicenter prospective study aims to evaluate the diagnostic performance of right ventricular sensing amplitude measured during cardiac implantable electronic device (CIED) implantation (pacemaker or defibrillator) to identify cardiac amyloidosis in patients with left ventricular hypertrophy and conduction abnormalities.
Patients aged 65 years or older referred for CIED implantation will be included. During the procedure, electrophysiological parameters will be recorded.
Additional assessments will be performed, including cardiac scintigraphy, biological analyses, and subcutaneous adipose tissue biopsy. The results of these investigations will be used to confirm or rule out cardiac amyloidosis.
Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC).
Eligibility criteria
Qualifiers
Patient referred for CIED implantation (pacemaker or Implantable Cardioverter Defibrillator with a pacemaker feature) due to at least one conduction abnormality (Atrioventricular block, Sinoatrial block or Atrial fibrillation with slow ventricular rate). Patients referred for implantation of an Implantable Cardioverter Defibrillator with a pacemaker feature can be included if they present one of these conduction abnormalities.
Left ventricular hypertrophy definite as maximal end-diastolic interventricular septum thickness ≥ 12mm
Patients aged ≥ 65 years
Written consent
Disqualifiers
Severe aortic stenosis (valve area ≤ 1 cm2)
Known cardiac amyloidosis
Indication for cardiac resynchronisation therapy
Indication for left bundle branch physiological pacing
Trial design
Treatments tested in this trial
- Cardiac amyloidosis screening during CIED implantation