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:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT05652218
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female aged ≥18 years
* Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads.
* NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic
* LVEF \>35% by clinically obtained echocardiogram overread by the study core-lab
* Demonstration of adequate echocardiographic images to allow for assessment of endpoints
* On a stable guideline directed HF medical regimen
* For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
* Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
Exclusion Criteria:
* Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study
* Treatment with another investigational drug or other intervention within 3 months
* Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months
* Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)
* Significant structural heart \[including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)\]
* Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg)
* Oxygen dependent chronic lung disease
* Prolonged episodes of AF (\>3 days or an AF burden \>10%) within the preceding 3 months
* Presence of cardiac pacemaker or implantable cardioverter defibrillator
* Prior mechanical tricuspid valve replacement
* Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus
* Known allergic reactions to components of the pacemaker or leads
* Febrile illness within 3 days of trial enrollment
* Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Control Participant Exclusion Criteria: same
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05652218
Study Brief:
Protocol Section:
NCT05652218