MultiPoint Pacing IDE Study (MPP IDE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: February 6, 2013
Last updated: April 24, 2015
Last verified: April 2015

February 6, 2013
April 24, 2015
April 2013
April 2015   (final data collection date for primary outcome measure)
  • Freedom from system-related complications [ Time Frame: 9-Month ] [ Designated as safety issue: Yes ]
  • Percentage of non-responders with multi-point pacing compared to biventricular pacing [ Time Frame: 9-Month ] [ Designated as safety issue: No ]
  • Freedom from system-related complications [ Time Frame: 9-Month ] [ Designated as safety issue: Yes ]
  • Proportion of non-responders between two arms of study [ Time Frame: 9-Month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01786993 on Archive Site
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MultiPoint Pacing IDE Study
MultiPoint Pacing IDE Study

This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with multi-point pacing compared to patient treatment with standard Biventricular 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 patients implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

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Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Device: MultiPoint Pacing
  • Device: Traditional Biventricular Pacing
  • Experimental: Multi-point pacing arm
    MultiPoint Pacing
    Intervention: Device: MultiPoint Pacing
  • Active Comparator: Biventricular arm
    Traditional Biventricular Pacing
    Intervention: Device: Traditional Biventricular Pacing
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
  • Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
  • Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
  • Have an existing Class I recalled lead
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  • Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
  • Have permanent atrial fibrillation (AF)
  • Have undergone a cardiac transplantation within 40 days of enrollment
  • Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
  • Are currently participating in a clinical investigation that includes an active treatment arm
  • Are pregnant or planning to become pregnant during the duration of the study
  • Have a life expectancy of less than 9 months due to any condition
  • Are less than 18 years of age
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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St. Jude Medical
St. Jude Medical
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Principal Investigator: Gery Tomassoni, MD Central Baptist Hospital
St. Jude Medical
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP