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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: MultiPoint Pacing
Device: Traditional Biventricular Pacing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MultiPoint Pacing IDE Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 506
Study Start Date: July 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-point pacing arm
MultiPoint Pacing
Device: MultiPoint Pacing
Active Comparator: Biventricular arm
Traditional Biventricular Pacing
Device: Traditional Biventricular Pacing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786993

  Show 49 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Gery Tomassoni, MD Central Baptist Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01786993     History of Changes
Other Study ID Numbers: 60029161/D
Study First Received: February 6, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014