Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEDevice 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
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRT Response Rate | 12 months | 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. |
| Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications | 36 months | 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. |
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom, United States
Participant flow
Pre-assignment details
In total 2044 subjects were enrolled into the study which included 103 PMCF subjects. For 9 of those subjects (PMCF = 4) the data could not be used and 30 subjects were consent ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up. | 2,005 |
| Total | 2,005 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-Month Primary Endpoint | Death | 152 |
| 12-Month Primary Endpoint | Withdrawal by Subject | 267 |
| Post Market Clinical Follow-Up ONLY | Death | 15 |
| Post Market Clinical Follow-Up ONLY | Withdrawal by Subject | 25 |
Baseline characteristics
| Characteristic | Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized Black | 86 Participants |
| Race/Ethnicity, Customized Other | 17 Participants |
| Race/Ethnicity, Customized Race Not Disclosed | 672 Participants |
| Race/Ethnicity, Customized White | 1230 Participants |
| Sex: Female, Male Female | 462 Participants |
| Sex: Female, Male Male | 1543 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 152 / 2,015 |
| other Total, other adverse events | 132 / 2,015 |
| serious Total, serious adverse events | 575 / 2,015 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Subjects must have a complete composite score at 12 months of follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. | CRT Response Rate | Improved | 918 Participants |
| Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. | CRT Response Rate | No Change | 312 Participants |
| Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. | CRT Response Rate | Worsened | 328 Participants |
Primary
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.
Time frame: 36 months
Population: A total of 103 subjects were classified as NG4 PMCF subjects at time of enrollment, among them 4 subjects data sets were not cleaned and unable to get corrected upon the end of the study. The final analyzed count is 99 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer. | Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications | 97.9 % of participants |