Cardiac AmyloidosisDETECT-AMYNCT07734285
Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy
A study testing Cardiac amyloidosis screening during CIED implantation in people with Cardiac Amyloidosis and Left Ventricular Hypertrophy, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Left Ventricular Hypertrophy, Conduction Abnormality
- What is being tested?
- Cardiac amyloidosis screening during CIED implantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 5 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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).
- Being tested
- Cardiac amyloidosis screening during CIED implantation
- Keywords
- Cardiac Amyloidosis, Pacemaker, Scintigraphy
- Medical subject headings
- Amyloid Neuropathies, Familial, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac amyloidosis screening during CIED implantationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Assessment During CIED Implantation | Other | Single Group Receives: Diagnostic Test: Cardiac amyloidosis screening during CIED implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During CIED implantation
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after CIED implantation (Day 0)
The implantation procedure duration (min) between patients with or without cardiac amyloidosis
Measured: During CIED implantation
The prevalence of cardiac amyloidosis in the study population
Measured: Up to 3 months after CIED implantation
The proportion of modifications in the treatment at the 6-month visit.
Measured: 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.
Measured: 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.
Measured: Inclusion and 6 months after CIED implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion5 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Le Corvoisier, MD, PhD, Study chair, Assistance public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734285
- Sponsor's protocol ID
- APHP240915
- Acronym
- DETECT-AMY
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07734285
- Acronym / sponsor ID
- DETECT-AMY / APHP240915
- Keywords
- Cardiac Amyloidosis, Pacemaker, Scintigraphy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 5 May 2030 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Assessment During CIED Implantation | Other | Diagnostic Test: Cardiac amyloidosis screening during CIED implantationSingle Group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac amyloidosis screening during CIED implantationProcedure 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 test | Diagnostic Assessment During CIED Implantation |
Primary outcome
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
Time frame: During CIED implantation
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.
11 secondary outcomes
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
Time frame: During hospitalization for CEID implantation (Day 0)
Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis
Time frame: During hospitalization for CEID implantation (Day 0)
Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis
Time frame: During hospitalization for CEID implantation (Day 0)
Diagnostic performance of maximal end-diastolic interventricular septal thickness
Time frame: During hospitalization for CEID implantation (Day 0)
Diagnostic performance of adipose tissue histology
Time frame: During hospitalization for CEID implantation (Day-0)
Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds
Time frame: 6 months after CIED implantation (Day 0)
The implantation procedure duration (min) between patients with or without cardiac amyloidosis
Time frame: During CIED implantation
The prevalence of cardiac amyloidosis in the study population
Time frame: Up to 3 months after CIED implantation
The proportion of modifications in the treatment at the 6-month visit.
Time frame: 6 months after CIED implantation
Change in RAND 36-Item Health Survey (SF-36) score
Time frame: Inclusion and 6 months after CIED implantation
Change in New York Heart Association (NYHA) Functional Classification
Time frame: Inclusion and 6 months after CIED implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Related trials for Cardiac Amyloidosis
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Le Corvoisier, MD, PhD study chair
Assistance public Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac amyloidosis screening during CIED implantation in people with Cardiac Amyloidosis and Left Ventricular Hypertrophy, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia BALOUL (0149 81 33 85, samia.baloul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis (time frame: During CIED implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.