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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: July 23, 2014
Last verified: July 2014

February 6, 2013
July 23, 2014
July 2014
March 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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
506
Not Provided
March 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01786993
60029161/D
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Gery Tomassoni, MD Central Baptist Hospital
St. Jude Medical
July 2014

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