Heart Failure
Conditions
Keywords
MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, SJM Quadripolar Biventricular Pacing
Brief summary
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.
Detailed description
Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.
Interventions
DEVICEMPP
MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
DEVICEBiV/MPP
MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement * Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion criteria
* Are expected to receive a heart transplant during the duration of the study * Have an epicardial ventricular lead system (Active or Inactive) * Are less than 18 years of age * Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm * Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of CRT Responders as Measured by the Clinical Composite Score (CCS) | One year | The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of MPP Programming in Months | One year | The duration of MPP programming in months in the treatment groups. |
| Number of MPP Programming Optimizations Per Subject | One year | The number of MPP programming optimizations per subject |
| Number of Subjects With Heart Failure Hospitalization | One year | HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure: * Hospitalization for HF ≥ 24 hours * Clinic or hospital visit for HF\<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators |
| Number of Subjects With Cardiovascular Hospitalization | One year | Number of subjects with cardiovascular hospitalization as reported by the sites |
| Change in Quality of Life | baseline and one year | The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. |
| Number of Deaths | One year | Overall mortality rate for all subjects who started the trial is summarized. |
| Change in Left Ventricular Ejection Fraction | baseline and one year | Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline) |
| Change in Left Ventricular End Systolic Volume | baseline and one year | Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months) |
| Number of Subjects With Heart Failure 30-day Hospitalization | 30 days | Number of subjects with heart failure 30-day hospitalization as reported by the sites |
Countries
Argentina, Colombia, Japan, United States
Participant flow
Pre-assignment details
This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group and the associated results presented.
Participants by arm
| Arm | Count |
|---|---|
| MPP Group MPP Group: Subjects programmed with MPP in the study are included in the analysis population. | 433 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 119 |
| Overall Study | Lost to Follow-up | 45 |
| Overall Study | MPP not programmed | 1,259 |
| Overall Study | Patient non-compliance | 42 |
| Overall Study | Physician Decision | 6 |
| Overall Study | System explant | 24 |
| Overall Study | Unsuccessful CRT implant | 93 |
| Overall Study | Withdrawal by other reasons | 25 |
| Overall Study | Withdrawal by Subject | 123 |
Baseline characteristics
| Characteristic | MPP Group |
|---|---|
| Age, Continuous | 70.4 Age STANDARD_DEVIATION 10.7 |
| Left Ventricular Ejection Fraction | 29.7 Percentage STANDARD_DEVIATION 10.4 |
| Left Ventricular End-Systolic Volume | 113.9 mL STANDARD_DEVIATION 67.7 |
| Quality of Life (MLWHF) | 39.9 scores on a scale STANDARD_DEVIATION 28.1 |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 35 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 34 Participants |
| Race/Ethnicity, Customized Other | 7 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 338 Participants |
| Region of Enrollment Argentina | 4 participants |
| Region of Enrollment Colombia | 3 participants |
| Region of Enrollment Japan | 12 participants |
| Region of Enrollment United States | 414 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 316 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 135 / 2,169 |
| other Total, other adverse events | 288 / 2,169 |
| serious Total, serious adverse events | 821 / 2,169 |
Outcome results
Primary
Number of CRT Responders as Measured by the Clinical Composite Score (CCS)
The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.
Time frame: One year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP Group | Number of CRT Responders as Measured by the Clinical Composite Score (CCS) | 350 Participants |
Other Pre-specified
Change in Left Ventricular Ejection Fraction
Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)
Time frame: baseline and one year
Population: The analysis population includes any subjects whose device is programmed with MPP. LVEF was optional data point in the study. Results were available from a very small number of subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPP Group | Change in Left Ventricular Ejection Fraction | 11.9 percentage | Standard Deviation 12 |
Other Pre-specified
Change in Left Ventricular End Systolic Volume
Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)
Time frame: baseline and one year
Population: The analysis population includes any subjects whose device is programmed with MPP. LVESV was optional data point in the study. Results were available from a very small number of subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPP Group | Change in Left Ventricular End Systolic Volume | 22.5 mL | Standard Deviation 57.3 |
Other Pre-specified
Change in Quality of Life
The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time frame: baseline and one year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPP Group | Change in Quality of Life | -17.4 score on a scale | Standard Deviation 24.4 |
Other Pre-specified
Duration of MPP Programming in Months
The duration of MPP programming in months in the treatment groups.
Time frame: One year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPP Group | Duration of MPP Programming in Months | 10.43 Months | Standard Deviation 2.58 |
Other Pre-specified
Number of Deaths
Overall mortality rate for all subjects who started the trial is summarized.
Time frame: One year
Population: The analysis population includes any subjects who started the trial.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP Group | Number of Deaths | 135 Participants |
Other Pre-specified
Number of MPP Programming Optimizations Per Subject
The number of MPP programming optimizations per subject
Time frame: One year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPP Group | Number of MPP Programming Optimizations Per Subject | 0.73 programming optimizations | Standard Deviation 0.74 |
Other Pre-specified
Number of Subjects With Cardiovascular Hospitalization
Number of subjects with cardiovascular hospitalization as reported by the sites
Time frame: One year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP Group | Number of Subjects With Cardiovascular Hospitalization | 142 Participants |
Other Pre-specified
Number of Subjects With Heart Failure 30-day Hospitalization
Number of subjects with heart failure 30-day hospitalization as reported by the sites
Time frame: 30 days
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP Group | Number of Subjects With Heart Failure 30-day Hospitalization | 6 Participants |
Other Pre-specified
Number of Subjects With Heart Failure Hospitalization
HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure: * Hospitalization for HF ≥ 24 hours * Clinic or hospital visit for HF\<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators
Time frame: One year
Population: The analysis population includes any subjects whose device is programmed with MPP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP Group | Number of Subjects With Heart Failure Hospitalization | 57 Participants |