None listed
Conditions
Interventions
Others(pacing strategy) : This study is a randomized clinical trial comparing a hemodynamics-guided optimized pacing strategy with a conventional pacing strategy in patients with cardiac amyloidosis u
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Presence of symptoms corresponding to New York Heart Association (NYHA) functional class II or higher despite optimal medical therapy. 3. Patients who have undergone implantation of a permanent pacemaker or an implantable cardioverter-defibrillator and meet at least one of the following indications for pacing: • Sick sinus syndrome with or without atrioventricular nodal dysfunction • Persistent or permanent atrial fibrillation with slow ventricular response • Chronotropic incompetence 4. Diagnosis of cardiac amyloidosis, defined by fulfillment of at least one of the following criteria: • Presence of a monoclonal protein on serum and/or urine studies, with confirmation of amyloid deposition by Congo red–positive myocardial or extracardiac tissue biopsy, identification of the amyloid protein subtype, and evidence of cardiac involvement • Absence of a monoclonal protein on serum and/or urine studies, with either grade =2 myocardial uptake on technetium-labeled bone scintigraphy (e.g., DPD scan) or Congo red–positive myocardial or extracardiac tissue biopsy with identification of the amyloid protein subtype and evidence of cardiac involvement
Exclusion criteria
Exclusion criteria: 1. Patients expected to have a ventricular pacing burden of =20% in whom adequate cardiac physiologic pacing (CPP) cannot be achieved. Cardiac physiologic pacing includes biventricular pacing, His bundle pacing (HBP), and left bundle branch area pacing (LBBAP). Adequate CPP is defined as a paced QRS duration =140 ms. 2. Patients in whom sufficient pacing dependency is not expected, defined as a baseline atrial rate =60 beats per minute in sinus rhythm or a baseline ventricular rate =60 beats per minute in atrial fibrillation or atrial flutter on device interrogation. 3. Presence of uncontrolled tachyarrhythmias. 4. Presence of untreated coronary artery disease requiring coronary revascularization. 5. Presence of moderate or greater valvular stenosis. 6. Presence of causes of uncontrolled dyspnea other than heart failure (e.g., uncontrolled chronic obstructive pulmonary disease, interstitial lung disease, asthma). 7. Pregnant or breastfeeding women. 8. Patients who refuse active medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Kansas City Cardiomyopathy Questionnaire, KCCQ-12 score | — |
Secondary
| Measure | Time frame |
|---|---|
| NTproBNP;Functional status;distance in 6-minute walk test;Occurrence of AF for non-AF patients, burden of AF for AF patients;Invasive hemodynamics parameters in right heart catheterization;Echocardiographic hemodynamics parameters;Pacing burden;HR distribution;Cardiopulmonary exercise test parameters;hospitalization due to heart failure;re-hospitalization due to any cause;all-cause mortality;cardiac mortality;CIED-related adverse event;CIED parameters;ECG parameters;Average HR | — |
Countries
Korea, Republic of
Contacts
Public ContactDarae Kim
Samsung Medical Center
Outcome results
None listed