Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

Study Overview
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Brief Summary
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To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

Official Title
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Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies. Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure. Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol Exclusion Criteria: Subject with documented life expectancy of less than 12 months Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device). Subject who have had a pre-existing CRT device Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager Women of childbearing potential who are or might be pregnant at time of study enrolment Any contra-indication to receive a CRT-D device per local guidelines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)|The optimization during the standard of care visits in the first 12 months following implantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT Response Rate | The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as no change. | 12 months | 
| Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications | Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in: Death Serious injury Correction of PG failure requiring invasive intervention Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint. | 36 months |