An interventional study of MPP in Heart Failure, sponsored by Abbott Medical Devices. Terminated at 206 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.
Exclusion Criteria:
Atrial Fibrillation:
MPP ON: feature is enabled
Device: MPP
MPP OFF: feature not enabled
All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
Percentage of Non-responder Patients Who Converted to Responders
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Time frame: Non-responder to responder conversion rate between randomization at 6 months and 12 months
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
Reduction of LVESV between baseline and 6 Months visit
Time frame: Baseline vs 6 Months
Clinical Composite Score Evaluation
Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
Time frame: Baseline vs 12 Months
Reverse Left Ventricular (LV) Remodeling
Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
Time frame: Baseline vs 12 Months
NYHA Class Changes
Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
Time frame: Baseline vs 12 Months
6MWT Changes
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Time frame: Baseline vs 12 Months
Patient's QoL Score Changes (MLWHF)
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
Time frame: Baseline vs 12 Months
The study enrolled eligible patients with a standard CRT indication after obtaining written informed consent. The implanting physician programmed biventricular pacing (BiVP) at implant in those patients who had the quadripolar CRT system successfully implanted The implanting physician programmed the LV pacing vector, A-V delay, and V-V delay settings at their discretion until the patient's randomization at 6 months.
| Milestone | MPP ON | BiVP |
|---|---|---|
| Started | 510 | 558 |
| Completed | 271 | 555 |
| Not completed | 239 | 3 |
| Withdrew: Mpp other programming | 239 | 0 |
| Withdrew: Rv only pacing | 0 | 3 |
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
| Participants | MPP ON | BiVP |
|---|---|---|
| Percentage of Non-responder Patients Who Converted to Responders | 84 | 170 |
Reduction of LVESV between baseline and 6 Months visit
| percentage of LVESV change | MPP ON | BiVP |
|---|---|---|
| Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase | 2.1 ± 11.2 | 0.1 ± 3.3 |
Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
| Participants | MPP ON | BiVP |
|---|---|---|
| Improved | 161 | 312 |
| Unchanged | 56 | 124 |
| Worsensed | 54 | 119 |
Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
| mL | MPP ON | BiVP |
|---|---|---|
| Reverse Left Ventricular (LV) Remodeling | 3.0 ± 24 | 3.8 ± 23.1 |
Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
| Participants | MPP ON | BiVP |
|---|---|---|
| Improved | 125 | 287 |
| Unchanged | 129 | 225 |
| Worsened | 12 | 20 |
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
| meters | MPP ON | BiVP |
|---|---|---|
| 6MWT Changes | 41.1 ± 113.6 | 46 ± 121.1 |
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
| score on a scale | MPP ON | BiVP |
|---|---|---|
| Patient's QoL Score Changes (MLWHF) | -11.6 ± 20.0 | -12.2 ± 21.7 |
Collected over 6 months to 12 months after randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MPP ON | 4/271 (1.5%) | 82/271 (30.3%) | 67/271 (24.7%) |
| BIVP | 18/555 (3.2%) | 190/555 (34.2%) | 118/555 (21.3%) |
| Event | MPP ON | BIVP |
|---|---|---|
| Exacerbation of Heart FailureCardiac disorders | 30/271 | 53/555 |
| Atrial or Ventricular ArrhythmiaCardiac disorders | 23/271 | 42/555 |
| Lead Dislodgement or MigrationProduct Issues | 8/271 | 36/555 |
| InfectionInfections and infestations | 7/271 | 16/555 |
| Bleeding/Hematoma/SeromaVascular disorders | 6/271 | 9/555 |
| Kidney DiseaseRenal and urinary disorders | 4/271 | 11/555 |
| Pulmonary EdemaCardiac disorders | 4/271 | 7/555 |
| StrokeNervous system disorders | 3/271 | 1/555 |
| PneumothoraxInjury, poisoning and procedural complications | 1/271 | 6/555 |
| Malignant TumorNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/271 | 6/555 |
| Event | MPP ON | BIVP |
|---|---|---|
| Atrial or Ventricular ArrhythmiaCardiac disorders | 24/271 | 41/555 |
| Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)Product Issues | 13/271 | 26/555 |
| Exacerbation of Heart FailureCardiac disorders | 5/271 | 13/555 |
| Elevated Pacing Thresholds/Loss of CaptureProduct Issues | 5/271 | 8/555 |
| Bleeding/Hematoma/SeromaVascular disorders | 1/271 | 10/555 |
| InfectionInfections and infestations | 3/271 | 4/555 |
| Coronary Sinus DissectionInjury, poisoning and procedural complications | 3/271 | 3/555 |
| Lead Dislodgement or MigrationProduct Issues | 3/271 | 2/555 |
| OversensingProduct Issues | 3/271 | 5/555 |
| HypotensionVascular disorders | 3/271 | 3/555 |
A race/ethnicity baseline was not collected in the study.
| Age, Continuous(years) | MPP ON | BiVP | Total |
|---|---|---|---|
| Mean | 68.4 ± 10.3 | 68.1 ± 10.6 | 68.2 ± 10.5 |
| Sex: Female, Male(Participants) | MPP ON | BiVP | Total |
|---|---|---|---|
| Female | 45 | 123 | 168 |
| Male | 226 | 432 | 658 |
| Race and Ethnicity Not Collected(Participants) | MPP ON | BiVP | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Type of Cardiomyopathy(Participants) | MPP ON | BiVP | Total |
|---|---|---|---|
| Ischemic | 147 | 278 | 425 |
| Non-ischemic | 124 | 277 | 401 |
| NYHA Class(Participants) | MPP ON | BiVP | Total |
|---|---|---|---|
| II | 129 | 272 | 401 |
| III | 137 | 268 | 405 |
| IV | 4 | 13 | 17 |
| Not done | 1 | 2 | 3 |
Showing the first 100 of 206 sites across 30 countries.
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Abbott Medical Devices