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Trial record 1 of 1 for:    MULTIPOINT PACING post market
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MultiPoint Pacing™ Post Market Study (MPP-PMS)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02832622
First received: July 5, 2016
Last updated: July 18, 2016
Last verified: July 2016
  Purpose
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Condition Intervention Phase
Heart Failure Device: MPP Device: BiV/MPP Device: BiV Device: Other Pacing Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MultiPoint Pacing™ Post Market Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Overall CRT response rate measured by the Clinical Composite Score [ Time Frame: One year ]

Other Outcome Measures:
  • Change in quality of life [ Time Frame: One year ]
  • Programming timing [ Time Frame: One year ]
  • Programming optimization (# of times and method used) [ Time Frame: One year ]
  • Heart failure hospitalization rate [ Time Frame: One year ]
  • Cardiovascular hospitalization rate [ Time Frame: One year ]
  • Heart failure 30-day hospitalization rate [ Time Frame: 30 days ]
  • Costs associated with heart failure-related healthcare utilizations [ Time Frame: One year ]
  • All-cause mortality [ Time Frame: One year ]
  • Change in left ventricular ejection fraction [ Time Frame: One year ]
  • Change in left ventricular end systolic volume [ Time Frame: One year ]

Estimated Enrollment: 2000
Study Start Date: July 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MPP Group
MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
Device: MPP
MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
Treatment Strategy (BiV/MPP) Group
MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., Biventricular (BiV) pacing ON at some point in months 1-9 and MPP ON for months 10-12)
Device: BiV/MPP
MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)
BiV Group
MPP OFF at the 12-month study visit and for at least three continuous months prior to 12-month assessment (i.e., BiV pacing ON for months 10-12)
Device: BiV
MPP OFF at the 12-month study visit and for at least three continuous months prior to 12-month assessment (i.e., BiV pacing ON for months 10-12)
Other Pacing Group
Other pacing schemes not covered above (Retrospective categorization implemented based on the usage of MPP or BiV pacing for 12 months)
Device: Other Pacing
Other pacing schemes not covered above (Retrospective categorization implemented based on the usage of MPP or BiV pacing for 12 months)

Detailed Description:
Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are indiciated for a CRT device
Criteria

Inclusion Criteria:

  • Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular 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:

  • Are expected to receive a heart transplant during the duration of the study
  • Have an epicardial ventricular lead system (Active or Inactive)
  • Are less than 18 years of age
  • Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
  • Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
  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: NCT02832622

Contacts
Contact: Kwangdeok Lee, PhD 972-526-9673 klee3@sjm.com

Locations
United States, California
Desert Heart Rhythm Consultants Recruiting
Palm Springs, California, United States, 92262
Contact: Hetal R Bhakta, MD    760-883-1600    bhaktamd@gmail.com   
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Clay Cohorn St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02832622     History of Changes
Other Study ID Numbers: SJM-CIP-10149
Study First Received: July 5, 2016
Last Updated: July 18, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by St. Jude Medical:
MultiPoint Pacing
Heart Failure
Cardiac Resynchronization Therapy
SJM Quadripolar Biventricular Pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017