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MultiPoint Pacing IDE Study (MPP IDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01786993
First received: February 6, 2013
Last updated: August 8, 2016
Last verified: August 2016
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Device: MultiPoint Pacing
Device: Traditional Biventricular Pacing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
455 out of 469 subjects with an attempted implant (97% success rate) received Quadripolar BiV pacing between implant and 3 months. At 3 months, responder status was assessed per Clincial Composite Score and 1:1 randomziation was stratified by responder status. 381 patients were randomized to either BiV (n = 180) or MPP (n = 201) at 3 months.

Reporting Groups
  Description
Multi-point Pacing Arm Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
Biventricular Arm Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.

Participant Flow:   Overall Study
    Multi-point Pacing Arm   Biventricular Arm
STARTED   201   180 
Per Protocol Population at 9 Months   189   170 
COMPLETED   189   170 
NOT COMPLETED   12   10 
Death                6                7 
Withdrawal by Subject                3                2 
Lost to Follow-up                0                1 
Subject Non-Compliance                1                0 
System Explant                1                0 
Hospice Admission                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
MultiPoint Pacing Arm Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
Biventricular Arm Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
Total Total of all reporting groups

Baseline Measures
   MultiPoint Pacing Arm   Biventricular Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   180   381 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (10)   68  (10)   68  (10) 
Gender 
[Units: Participants]
     
Female   73   61   134 
Male   128   119   247 
Region of Enrollment 
[Units: Participants]
     
United States   201   180   381 
Ethnicity 
[Units: Participants]
     
Hispanic or Latino   10   5   15 
Non-Hispanic or Latino   191   175   366 
RACE 
[Units: Participants]
     
White   176   163   339 
Black or African American   19   16   35 
Asian   2   0   2 
Other   4   1   5 
QRS Duration 
[Units: Ms]
Mean (Standard Deviation)
 158  (24)   154  (20)   156  (22) 
QRS Morphology 
[Units: Participants]
     
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 
[Units: Participants]
     
Ischemic   96   88   184 
Non-ischemic   103   91   194 
None   2   1   3 


  Outcome Measures
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1.  Primary:   Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion   [ Time Frame: Implant to 9 months ]

2.  Primary:   Percentage of Non-responders With MPP Compared to Biventricular Pacing   [ Time Frame: 3 months to 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Studies
Organization: St. Jude Medical
phone: 972-309-8000 ext 8087
e-mail: ccohorn@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01786993     History of Changes
Other Study ID Numbers: 60029161/D
Study First Received: February 6, 2013
Results First Received: April 15, 2016
Last Updated: August 8, 2016