A Phase 3 interventional study of MultiPoint Pacing and Traditional Biventricular Pacing in Heart Failure, sponsored by Abbott Medical Devices. Completed at 49 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices · Phase 3, Interventional, and Treatment
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 506 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
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Exclusion Criteria:
MultiPoint Pacing
Device: MultiPoint Pacing
Traditional Biventricular Pacing
Device: Traditional Biventricular Pacing
Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion
A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.
Time frame: Implant to 9 months
Percentage of Non-responders With MPP Compared to Biventricular Pacing
The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below: * Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation * Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation. * Unchanged - patient was neither improved nor worsened For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.
Time frame: 3 months to 9 months
The study enrolled 506 subjects at 49 investigational centers located in the U.S. A patient was considered enrolled upon signing informed consent. The first subject was enrolled on April 25, 2013. The study was double-blinded (the study subjects and the authorized personnel conducting the NYHA Class and Patient Global assessments were blinded).
| Milestone | Multi-point Pacing Arm | Biventricular Arm |
|---|---|---|
| Started | 201 | 180 |
| Per protocol population at 9 months | 189 | 170 |
| Completed | 189 | 170 |
| Not completed | 12 | 10 |
| Withdrew: Death | 6 | 7 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Subject non-compliance | 1 | 0 |
| Withdrew: System explant | 1 | 0 |
| Withdrew: Hospice admission | 1 | 0 |
A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.
| Event-Free Probability | BiV/MPP Patients |
|---|---|
| Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion | 0.932 (0.904 to 0.951) |
The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below: * Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation * Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation. * Unchanged - patient was neither improved nor worsened For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.
| percentage of patients | MultiPoint Pacing Arm | Biventricular Arm |
|---|---|---|
| Percentage of Non-responders With MPP Compared to Biventricular Pacing | 29.9 | 25 |
Collected over 3-month randomization to 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MultiPoint Pacing Arm | — | 4/201 (2%) | 40/201 (19.9%) |
| Biventricular Arm | — | 3/180 (1.7%) | 5/180 (2.8%) |
| Event | MultiPoint Pacing Arm | Biventricular Arm |
|---|---|---|
| LV Lead Dislodgement or MigrationCardiac disorders | 1/201 | 3/180 |
| RA/RV Lead Dislodgement or MigrationCardiac disorders | 1/201 | 0/180 |
| Pulse Generator Erosion/ExtrusionCardiac disorders | 1/201 | 0/180 |
| Generator MalfunctionCardiac disorders | 1/201 | 0/180 |
| Event | MultiPoint Pacing Arm | Biventricular Arm |
|---|---|---|
| Phrenic Nerve/Diaphragmatic Stimulation Related to LV LeadCardiac disorders | 21/201 | 0/180 |
| Artifact Observed on Atrial ChannelCardiac disorders | 10/201 | 0/180 |
| LV Lead Elevated Pacing ThresholdsCardiac disorders | 3/201 | 0/180 |
| RA/RV Lead OversensingCardiac disorders | 1/201 | 2/180 |
| Pulse Generator OversensingCardiac disorders | 1/201 | 2/180 |
| LV Lead Loss of CaptureCardiac disorders | 2/201 | 0/180 |
| Intolerance to BiV PacingCardiac disorders | 0/201 | 1/180 |
| Erythema to Lateral Aspect of Incision SiteCardiac disorders | 0/201 | 1/180 |
| Rise in Threshold And Exit Block Related to LV LeadCardiac disorders | 1/201 | 0/180 |
| RA/RV Lead Elevated Pacing ThresholdsCardiac disorders | 1/201 | 0/180 |
A total of 381 subjects were randomized at 3 months, of whom 180 were in the BiV arm and 201 were in the MPP arm.
| Age, Continuous(years) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Mean | 67 ± 10 | 68 ± 10 | 68 ± 10 |
| Sex: Female, Male(Participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Female | 73 | 61 | 134 |
| Male | 128 | 119 | 247 |
| Region of Enrollment(participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| United States | 201 | 180 | 381 |
| Ethnicity(participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 5 | 15 |
| Non-Hispanic or Latino | 191 | 175 | 366 |
| RACE(participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| White | 176 | 163 | 339 |
| Black or African American | 19 | 16 | 35 |
| Asian | 2 | 0 | 2 |
| Other | 4 | 1 | 5 |
| QRS Duration(ms) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Mean | 158 ± 24 | 154 ± 20 | 156 ± 22 |
| QRS Morphology(participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Left Bundle Branch Block (LBBB) | 146 | 139 | 285 |
| Right Bundle Branch Block (RBBB) | 21 | 20 | 41 |
| Interventricular Conduction Delay (IVCD) | 32 | 21 | 53 |
| Unknown | 2 | 0 | 2 |
| Cardiomyopathy Etiology(participants) | MultiPoint Pacing Arm | Biventricular Arm | Total |
|---|---|---|---|
| Ischemic | 96 | 88 | 184 |
| Non-ischemic | 103 | 91 | 194 |
| None | 2 | 1 | 3 |
Plan to share: Yes — The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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