NCT07734285Not yet recruiting
Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 242 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Amyloidosis
- NCT number
- NCT07734285
What you commit to
- Study type: Interventional
- Planned participants: 242
- From Sept 2026 to the primary completion date, Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.
Other illness
- Known cardiac amyloidosis
- Indication for cardiac resynchronisation therapy
Lab values
- Ejection fraction \< 45% on echocardiography.
Other
- Severe aortic stenosis (valve area ≤ 1 cm2)
- Indication for left bundle branch physiological pacing
- 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.
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.