Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis

Korábbi kezelés

• MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, cardioversion, valve repair/replacement, hospitalization for decompensated heart failure or cardiac resynchronisation therapy within 12 weeks prior to enrollment.
• Enrollment in other interventional device or drug trials during the study period, with the exception of open label extension studies
• Initiation of SGLT2-inhibitor or mineralocorticoid receptor antagonist within 4 weeks prior to enrollment
• Initiation or change in loop diuretic therapy within 4 weeks prior to enrollment

Más betegség

• Planned coronary revascularization, ablation of atrial flutter/fibrillation, or any severe (obstructive or regurgitant) valvular heart disease expected to require intervention during the trial in the investigator's opinion.
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• Presence of any other disease than heart failure with a life expectancy of < 1year in the investigators opinion
• Listed for cardiac transplantation

Egyéb

• Inability to perform the 6-minute walk test.
• Planned upgrade to CRT or conduction system pacing in patients with RV pacing.
• More than moderate valvular stenosis or regurgitation

• ATTR-CM defined as one of the following:
• a.Positive cardiac biopsy for ATTR amyloidosis
• b.Positive extra-cardiac biopsy for ATTR amyloidosis AND cardiac involvement demonstrated by CMR or echocardiography
• c.Grade 2-3 uptake on DPD-scintigraphy AND negative serum free light chain and negative urine and serum immunofixation AND cardiac involvement demonstrated by CMR or echocardiography
• Ongoing treatment with a transthyretin stabilizer or silencer OR considered not to be a candidate for these therapies with no planned initiation during the study period.
• NYHA functional class II-III
• Pre-existing pacemaker and either:
• a.Atrial pacing with minimal RV pacing (<2%), or
• b.His bundle or left bundle branch area pacing, or
• c.Biventricular pacing, or
• d.Ongoing RV pacing with a high degree of RV pace (>80%)
• NT-proBNP >600 ng/L
• Age ≥18 years
• Ability and willingness to provide written informed consent
• Pacing >80% with a programmed lower rate of 60 (AAI/CSP/CRT/RV-pace)