Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAssistance Publique - Hôpitaux de Paris

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

Treatment groups

242 Participants
are divided into 1 treatment group

Locations

This trial has no locations