Accelerated LBBP for Patients With RHF and Severe TR

Korábbi kezelés

• Prior implantation of a cardiac pacemaker.
• Participation in another drug or medical device clinical trial that has not yet been completed.

Más betegség

• Mean pulmonary artery pressure (mPAP) > 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm.
• Current use of heart rate-lowering medications, such as beta-blockers, digoxin, ivabradine, etc.

Laborértékek

• Left ventricular ejection fraction (LVEF) < 50% or left ventricular end-diastolic diameter (LVEDD) > 56 mm as measured by echocardiography.

Egyéb

• Moderate or greater left-sided valvular regurgitation or stenosis.
• Untreated hypothyroidism.
• Deemed unsuitable for participation in this clinical trial by the investigator.

• Mean resting heart rate ≤ 65 beats/min (based on a resting electrocardiogram).
• Clinically confirmed right-sided heart failure, requiring ≥2 diuretic units to fully control edema, or having persistent grade ≥1 edema despite diuretic therapy.
  • Diuretic unit definition: expressed as the number of daily doses at the standard oral dose. For example, the standard units for furosemide, torasemide, and spironolactone are 20 mg/day, 10 mg/day, and 20 mg/day, respectively. If a patient takes furosemide 20 mg twice daily and spironolactone 20 mg once daily, the total diuretic units equal 3.
• Echocardiography shows severe or greater tricuspid regurgitation.
• With/without an indication for permanent pacemaker implantation.
• Is able to understand the purpose of the trial, voluntarily participates and signs written informed consent, and is willing to complete follow-up visits as required by the protocol.