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Not yet recruitingNCT07734285DETECT-AMYUpdated Jul 29, 2026

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

An interventional study of Cardiac amyloidosis screening during CIED implantation in Cardiac Amyloidosis, Left Ventricular Hypertrophy and Conduction Abnormality, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Cardiac Amyloidosis
  • Left Ventricular Hypertrophy
  • Conduction Abnormality

Keywords

  • Cardiac Amyloidosis
  • Pacemaker
  • Scintigraphy
03

In context

Amyloid Neuropathies, Familial

188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.

This study's planned enrollment of 242 is above the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.

Browse Amyloid Neuropathies, Familial studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe aortic stenosis (valve area ≤ 1 cm2)
  • Known cardiac amyloidosis
  • Indication for cardiac resynchronisation therapy
  • Indication for left bundle branch physiological pacing
  • \< 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
242 participants (estimated)

Study arms

  • Other
    Diagnostic Assessment During CIED Implantation

    Single Group

    Diagnostic Test: Cardiac amyloidosis screening during CIED implantation

Interventions

  • Diagnostic testCardiac 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.

06

What researchers measure

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.

    Time frame: During CIED implantation

Secondary outcomes

  1. 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.

    Time frame: During hospitalization for CEID implantation (Day 0)

  2. 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.

    Time frame: During hospitalization for CEID implantation (Day 0)

  3. 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.

    Time frame: During hospitalization for CEID implantation (Day 0)

  4. 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.

    Time frame: During hospitalization for CEID implantation (Day 0)

  5. 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.

    Time frame: During hospitalization for CEID implantation (Day-0)

  6. 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.

    Time frame: 6 months after CIED implantation (Day 0)

  7. The implantation procedure duration (min) between patients with or without cardiac amyloidosis

    Time frame: During CIED implantation

  8. The prevalence of cardiac amyloidosis in the study population

    Time frame: Up to 3 months after CIED implantation

  9. The proportion of modifications in the treatment at the 6-month visit.

    Time frame: 6 months after CIED implantation

  10. 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.

    Time frame: Inclusion and 6 months after CIED implantation

  11. 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.

    Time frame: Inclusion and 6 months after CIED implantation

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.

Of 30 interventional studies with no phase under Amyloid Neuropathies, Familial, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 39 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2026
First posted
Jul 29, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 1, 2029
CompletionEst.
May 5, 2030
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07734285
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 1, 2029 (estimated)
Completion
May 5, 2030 (estimated)
Last update
Jul 29, 2026

Study contacts

Samia BALOUL
Contact
samia.baloul@aphp.fr
0149 81 33 85
Philippe Le Corvoisier, MD, PhD
Contact
philippe.lecorvoisier@aphp.fr
01 49 81 37 96
Philippe Le Corvoisier, MD, PhD
study chair · Assistance public Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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