Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy (DETECT-AMY)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Left Ventricular Hypertrophy; Cardiac Amyloidosis; Conduction Abnormality
• Intervention / Treatment: Diagnostic test: Cardiac amyloidosis screening during CIED implantation

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samia BALOUL; Phone Number: 0149 81 33 85; Email: samia.baloul@aphp.fr
• Study Contact Backup: Name: Philippe Le Corvoisier, MD, PhD; Phone Number: 01 49 81 37 96; Email: philippe.lecorvoisier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Diagnostic Assessment During CIED Implantation; Single Group

Diagnostic test: Cardiac amyloidosis screening during CIED implantation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.	During hospitalization for CEID implantation (Day 0)
Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.	During hospitalization for CEID implantation (Day 0)
Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.	During hospitalization for CEID implantation (Day 0)
Diagnostic performance of maximal end-diastolic interventricular septal thickness	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of maximal end-diastolic interventricular septum thickness at echocardiography for identifying patients with cardiac amyloidosis.	During hospitalization for CEID implantation (Day 0)
Diagnostic performance of adipose tissue histology	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of histological analysis of adipose tissue for identifying patients with cardiac amyloidosis.	During hospitalization for CEID implantation (Day-0)
Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds	The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of 12-lead electrocardiogram data (low voltage in limb leads) for identifying patients with cardiac amyloidosis.	6 months after CIED implantation (Day 0)
The implantation procedure duration (min) between patients with or without cardiac amyloidosis		During CIED implantation
The prevalence of cardiac amyloidosis in the study population		Up to 3 months after CIED implantation
The proportion of modifications in the treatment at the 6-month visit.		6 months after CIED implantation
Change in RAND 36-Item Health Survey (SF-36) score	Change in health-related quality of life between inclusion and the 6-month visit, assessed using the RAND 36-Item Health Survey, Version 1.0 (SF-36). The questionnaire comprises 36 items grouped into 8 domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.	Inclusion and 6 months after CIED implantation
Change in New York Heart Association (NYHA) Functional Classification	Change in New York Heart Association (NYHA) Functional Classification between baseline and the 6-month visit in patients with and without cardiac amyloidosis. The NYHA Functional Classification ranges from Class I to Class IV, with higher class indicating worse functional status.	Inclusion and 6 months after CIED implantation

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Philippe Le Corvoisier, MD, PhD, Assistance public Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 5, 2030

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pacemaker; Scintigraphy; Cardiac Amyloidosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Cardiomegaly; Amyloid Neuropathies; Amyloidosis, Familial; Hypertrophy; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertrophy, Left Ventricular; Amyloid Neuropathies, Familial
• Other Study ID Numbers: APHP240915

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No