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

NCT07734285 | Not Yet Recruiting

• 1 other identifier: APHP240915
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Left Ventricular Hypertrophy; Conduction Abnormality; Cardiac Amyloidosis

Keywords

Cardiac Amyloidosis; Pacemaker; Scintigraphy

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis

  The area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude, measured during CIED implantation in patients with conduction abnormalities, for the identification of patients with cardiac amyloidosis.

  During CIED implantation

Secondary Outcomes (11)

• Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis

  During hospitalization for CEID implantation (Day 0)

• Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis

  During hospitalization for CEID implantation (Day 0)

• Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis

  During hospitalization for CEID implantation (Day 0)

• Diagnostic performance of maximal end-diastolic interventricular septal thickness

  During hospitalization for CEID implantation (Day 0)

• Diagnostic performance of adipose tissue histology

  During hospitalization for CEID implantation (Day-0)

Study Arms (1)

Diagnostic Assessment During CIED Implantation

OTHER

Single Group

Diagnostic Test: Cardiac amyloidosis screening during CIED implantation

Interventions

Cardiac amyloidosis screening during CIED implantation DIAGNOSTIC_TEST

Procedure of CIED implantation will not be modified by inclusion in the study. However, several exams will be performed to confirm or ruled out the diagnosis of cardiac amyloidosis: During the procedure: Subcutaneous adipose tissue sampling Collection of a subcutaneous adipose tissue sample during device implantation for histological analysis to detect amyloid deposits. Blood sampling for serum free light chain assay, serum and urine electrophoresis with immunofixation (baseline visit) Diagnostic Test: 99mTc-DPD or HMDP Scintigraphy Cardiac scintigraphy performed within 3 months after implantation to assess myocardial tracer uptake and detect cardiac amyloidosis.

Diagnostic Assessment During CIED Implantation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Le Corvoisier, MD, PhD

  Assistance public Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Samia BALOUL

CONTACT

0149 81 33 85; samia.baloul@aphp.fr

Philippe Le Corvoisier, MD, PhD

CONTACT

01 49 81 37 96; philippe.lecorvoisier@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 5, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-01