Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT07272395
Eligibility Criteria:
Inclusion Criteria
* Adults aged 18 years or older.
* Scheduled to undergo implantation of a clinically indicated pacemaker, ICD, or CRT device.
* Able to undergo transthoracic echocardiography, VEXUS ultrasound assessment, and non-contrast cardiac MRI.
* Able to provide written informed consent.
Exclusion Criteria
* Contraindication to cardiac MRI (e.g., severe claustrophobia or MRI-unsafe implanted material).
* Inability to undergo echocardiography or ultrasound assessment.
* Known pulmonary arterial hypertension (Group 1 PH).
* Significant congenital heart disease.
* Patients with mechanical or bioprosthetic heart valve replacement
* Severe left-sided valvular disease (severe AS or severe MR).
* Chronic kidney disease stage 4 or 5 (eGFR \< 30 mL/min/1.73m²).
* End-stage renal disease requiring dialysis.
* Primary hyperparathyroidism.
* Hypophosphataemia or hyperphosphataemia requiring treatment.
* Active or uncontrolled bone metabolism disorders (e.g., osteomalacia, Paget's disease).
* Recent fracture or major orthopaedic surgery within the past 3 months.
* Active systemic inflammatory or autoimmune disease.
* Active malignancy or malignancy requiring ongoing treatment.
* Active infection at the time of enrolment.
* Pregnancy or breastfeeding.
* Haemodynamic instability at the time of enrolment.
* Expected survival less than 6 months due to non-cardiac conditions.
* Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07272395
Study Brief:
Protocol Section:
NCT07272395