Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy | NCT07734285

NCT07734285

Overview

NCT ID: NCT07734285
Lead Sponsor: Assistance Publique - Hôpitaux de ParisOTHER
Official Title: Diagnostic Performance of Right Ventricular Sensing Amplitude and Other Electrophysiological,Echographic, and Histological Parameters in Cardiac Amyloidosis Among Patients With Left Ventricular Hypertrophy: a Multicenter Prospective Study
Brief Summary: 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).

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Patient affiliated to a social security

Exclusion Criteria:

Severe aortic stenosis (valve area ≤ 1 cm2)

Known cardiac amyloidosis

Indication for cardiac resynchronisation therapy

Indication for left bundle branch physiological pacing

Ejection fraction < 45% on echocardiography.

Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.

Patient on AME (state medical aid)

Adults subject to a legal protection measure (guardianship, curatorship, or safeguard of justice).

Patients deprived of their liberty by a judicial or administrative decision.