All patients undergoing pacemaker-related procedures at participating institutions will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator (ICD), or cardiac resynchronization therapy (CRT) device
Conditions
Interventions
None listed
Sponsors
LANDMARK study investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing pacemaker-related procedures will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator ICD, or cardiac resynchronization therapy CRT device.
Exclusion criteria
Exclusion criteria: Patients who underwent leadless pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy endpoints will include all-cause mortality, cardiac death, heart failure, and peri-procedural and late complications. The final analysis will be conducted after completion of the 5-year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| LBBAP Evaluation of short and long term outcomes based on baseline patient characteristics and the presence or absence of peri and post procedural complications Assessment of procedural success rate based on predefined success criteria Evaluation of the learning curve effect Impact of institutional operator volume on procedural success rates Comparative evaluation of hemodynamics and prognosis between LBBP and LVSP Assessment of lead durability Evaluation of efficacy in specific cardiomyopathies eg amyloidosis Assessment of peri procedural complication rates Evaluation of safety and efficacy in iatrogenic atrioventricular block Assessment of reduction in the incidence of supraventricular arrhythmias These outcomes will be compared with the non conduction system pacing non CSP cohort according to the study design Evaluation of the incidence and prognosis of pacing induced cardiomyopathy at 5 years in CSP versus non CSP cohorts BBP Evaluation of clinical outcomes according to atrial pacing site Assessment of procedural success rate of BBP Validation of success criteria for BBP Evaluation of the impact of reactive ATP and atrial pacing site on supraventricular tachyarrhythmias Assessment of the incidence and persistence of supraventricular arrhythmias according to pacing site ICD CRT Evaluation of the efficacy of LOT CRT in Japan Assessment of the efficacy of ATP delivered via SelectSecure leads in LOT CRTD Evaluation of efficacy in ischemic vs non ischemic cardiomyopathy and in left bundle branch block vs left ventricular conduction delay Assessment of the impact of BBP on the incidence of supraventricular arrhythmias in ICD patients These outcomes will be compared with conventional ICD CRT cohorts according to the study design | — |
Countries
Japan
Contacts
Public ContactNoriaki Moriyama
Shonan Kamakura General Hospital Cardiology
Outcome results
None listed