ClinicalTrials.gov record NCT07734285

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age65 years old and older

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This multicenter prospective interventional study tests whether right ventricular (RV) sensing amplitude recorded during cardiac implantable electronic device (CIED) implantation can help identify cardiac amyloidosis in people with left ventricular hypertrophy and conduction abnormalities. During the standard implantation, electrophysiological parameters will be recorded and a subcutaneous adipose tissue sample taken; blood tests and 99mTc‑DPD or HMDP cardiac scintigraphy will also be done. Diagnostic performance will be measured using the area under the receiver operating characteristic curve (AUROC).

What it is studying. Whether RV sensing amplitude measured during CIED implantation can identify cardiac amyloidosis, and how other measures — right atrial sensing amplitude, atrial and ventricular pacing thresholds, interventricular septum thickness on echocardiography, adipose tissue histology, ECG findings, and cardiac scintigraphy — perform for diagnosis.

What the researchers hope to learn. To evaluate the diagnostic accuracy (AUROC) of RV sensing amplitude for detecting cardiac amyloidosis; to assess diagnostic performance of right atrial sensing, pacing thresholds, septal thickness, adipose tissue histology, ECG features, and scintigraphy; to estimate prevalence of cardiac amyloidosis in this study population; and to report implantation duration and 6‑month changes in treatment, NYHA class, and SF‑36 scores.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: Cardiac amyloidosis screening during CIED implantation

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would have your planned pacemaker or ICD implantation, with the care team recording electrical measurements from the device leads (sensing amplitudes and pacing thresholds) during the procedure; a small subcutaneous fat sample will also be collected during implantation for histology. At the start you will give blood and urine samples for tests including serum free light chain assay and serum/urine electrophoresis with immunofixation. Within three months you will have a cardiac scintigraphy (99mTc‑DPD or HMDP) to assess myocardial tracer uptake. About six months after implantation you will have follow-up assessments including a 12‑lead ECG, health and quality-of-life questionnaires (SF-36), NYHA functional class assessment, and recording of any changes in treatment.

How the study is structured. A single-group, non-masked interventional diagnostic study. Participants receive their planned CIED implantation (procedure is not changed by the study) while the clinical team records atrial and ventricular sensing amplitudes and pacing thresholds and collects a subcutaneous adipose tissue sample. Baseline blood tests are taken and cardiac scintigraphy (99mTc‑DPD or HMDP) is performed within 3 months after implantation. Some diagnostic measures are assessed during implantation and additional outcomes (quality of life, NYHA class, and treatment changes) are assessed at a 6-month visit.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Cardiac Amyloidosis; Left Ventricular Hypertrophy; Conduction Abnormality. Does it apply to my diagnosis?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Sep 1, 2026 (estimated)
Primary completion: Dec 1, 2029 (estimated)
Study completion: May 5, 2030 (estimated)
Target enrollment: 242 participants (estimated)
Last updated on registry: Jul 29, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Samia BALOUL 📞 0149 81 33 85 ✉ samia.baloul@aphp.fr
Philippe Le Corvoisier, MD, PhD 📞 01 49 81 37 96 ✉ philippe.lecorvoisier@aphp.fr

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials