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Not Yet Recruiting NCT07734285

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

Conditions: Cardiac Amyloidosis, Left Ventricular Hypertrophy, Conduction Abnormality

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 242
Sponsor: Assistance Publique - Hôpitaux de Paris

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).

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07734285). StuddyBuddy aggregates publicly available trial information.