MultiPoint Pacing IDE Study (MPP IDE)
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.
|Heart Failure||Device: MultiPoint Pacing Device: Traditional Biventricular Pacing||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||MultiPoint Pacing IDE Study|
- Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion [ Time Frame: Implant to 9 months ]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.
- Percentage of Non-responders With MPP Compared to Biventricular Pacing [ Time Frame: 3 months to 9 months ]
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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Multi-point pacing arm
Device: MultiPoint 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.
Active Comparator: Biventricular arm
Traditional Biventricular Pacing
Device: Traditional Biventricular Pacing
Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786993
Show 49 Study Locations
|Principal Investigator:||Gery Tomassoni, MD||Central Baptist Hospital|