Heart Failure
Conditions
Keywords
Heart Failure, Cardiac Resynchronization Therapy, Quadripolar Left Ventricular Lead, Multipoint Pacing, Hemodynamic Response
Brief summary
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
Detailed description
The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder\* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline. \*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.
Interventions
DEVICEMPP ON
Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker). * Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead. * In sinus rhythm at baseline visit. * Patients with Left Bundle Branch Block (LBBB) * Must be willing and able to comply with study requirements. * Older than 18 years * Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.
Exclusion criteria
* Already has a CRT device implanted. * Myocardial Infarction or unstable angina within 40 days prior the enrollment. * New York Heart Association (NYHA) Class IV * Recent cardiac revascularization in the 4 weeks prior to enrollment. * Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment. * Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months. * Primary valvular disease requiring surgical intervention. * Atrial Fibrillation (AF): * Persistent AF at the time of enrollment or 30 days prior the enrollment * Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment * Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained. * Undergone a cardiac transplantation or being waiting for it * Life expectancy \< 6 months * Pregnancy or planning to become pregnant * Unable to comply with the follow up schedule * Currently participating in any other clinical investigation.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of CRT Responders | 6 months | The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of \>15 % in LVESV, as measured by echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LV Echocardiographic Parameters | Baseline and 6 months | An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant. The values of change with positive numbers represent increases and negative numbers represent decreases. |
| Number of CRT Super-responders | 6 months | The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of \>14% at 6 months post-implant compared to baseline. |
| Rates of Hospitalization and Mortality | 6 months | The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant. |
| Change in NYHA Classification | 6 months | The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification. The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. |
Countries
Spain
Participant flow
Recruitment details
Subject enrollment began on 11-Feb-2016 and the last enrollment occurred on 13-Aug-2018.
Participants by arm
| Arm | Count |
|---|---|
| MPP ON MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | MPP programmed to OFF | 2 |
| Overall Study | Study echo not performed | 5 |
| Overall Study | Unable to program MPP | 9 |
| Overall Study | Unsuccessful implant | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MPP ON | — |
|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 8.4 | — |
| Cardiomyopathy Etiology Ischemic | 44 Participants | — |
| Cardiomyopathy Etiology Non-ischemic | 61 Participants | — |
| Left Ventricular End Systolic Volume (LVESV) | 127.78 mililiters STANDARD_DEVIATION 48.87 | — |
| New York Heart Association (NYHA) Classification NYHA I | 6 Participants | — |
| New York Heart Association (NYHA) Classification NYHA II | 60 Participants | — |
| New York Heart Association (NYHA) Classification NYHA III | 39 Participants | — |
| New York Heart Association (NYHA) Classification NYHA IV | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Portugal | 8 participants | — |
| Region of Enrollment Spain | 97 participants | — |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 78 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 105 |
| other Total, other adverse events | 11 / 105 |
| serious Total, serious adverse events | 16 / 105 |
Outcome results
Primary
Number of CRT Responders
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of \>15 % in LVESV, as measured by echocardiography.
Time frame: 6 months
Population: The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP ON | Number of CRT Responders | 53 Participants |
p-value: 0.0435Exact binomial
Secondary
Change in NYHA Classification
The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification. The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
Time frame: 6 months
Population: Subjects implanted with a CRT-D device and a Quartet quadripolar LV lead, programmed with the MPP feature activated and who had a NYHA classification evaluation at baseline and 6 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MPP ON | Change in NYHA Classification | Improvement in NYHA classification | 26 Participants |
| MPP ON | Change in NYHA Classification | Worsening in NYHA classification | 2 Participants |
| MPP ON | Change in NYHA Classification | NYHA classification unchanged | 54 Participants |
Secondary
Changes in LV Echocardiographic Parameters
An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant. The values of change with positive numbers represent increases and negative numbers represent decreases.
Time frame: Baseline and 6 months
Population: The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPP ON | Changes in LV Echocardiographic Parameters | LVEF | 9.37 Percent change | Standard Deviation 12.2 |
| MPP ON | Changes in LV Echocardiographic Parameters | LVESV | -25.33 Percent change | Standard Deviation 31.42 |
| MPP ON | Changes in LV Echocardiographic Parameters | LVEDV | -14.90 Percent change | Standard Deviation 28.09 |
| MPP ON | Changes in LV Echocardiographic Parameters | LVESD | -10.72 Percent change | Standard Deviation 14.53 |
| MPP ON | Changes in LV Echocardiographic Parameters | LVEDD | -7.23 Percent change | Standard Deviation 11.72 |
Secondary
Number of CRT Super-responders
The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of \>14% at 6 months post-implant compared to baseline.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MPP ON | Number of CRT Super-responders | 27 Participants |
Secondary
Rates of Hospitalization and Mortality
The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MPP ON | Rates of Hospitalization and Mortality | All-cause mortality | 2 Participants |
| MPP ON | Rates of Hospitalization and Mortality | All-cause hospitalization | 12 Participants |
| MPP ON | Rates of Hospitalization and Mortality | Heart failure hospitalization | 1 Participants |
| MPP ON | Rates of Hospitalization and Mortality | Cardiovascular hospitalization | 4 Participants |
| MPP ON | Rates of Hospitalization and Mortality | Combined mortality/heart failure hospitalization | 2 Participants |
| MPP ON | Rates of Hospitalization and Mortality | Combined mortality/cardiovascular hospitalization | 6 Participants |