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OpenTrials
Completed

NCT Number: NCT02832622

MultiPoint Pacing™ Post Market Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Argentino de Diagnostico y Tratamiento, Caba, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPP

Device

MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)

BiV/MPP

Device

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)

Primary outcomes

  1. Number of CRT Responders as Measured by the Clinical Composite Score (CCS)

    Time frame: One year

    The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.

Other outcomes

  1. Change in Quality of Life

    Time frame: baseline and one year

    The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline).

    MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.

  2. Duration of MPP Programming in Months

    Time frame: One year

    The duration of MPP programming in months in the treatment groups.

  3. Number of MPP Programming Optimizations Per Subject

    Time frame: One year

    The number of MPP programming optimizations per subject

  4. Number of Subjects With Heart Failure Hospitalization

    Time frame: One year

    HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure:

    • Hospitalization for HF ≥ 24 hours
    • Clinic or hospital visit for HF<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators

  5. Number of Subjects With Cardiovascular Hospitalization

    Time frame: One year

    Number of subjects with cardiovascular hospitalization as reported by the sites

  6. Number of Subjects With Heart Failure 30-day Hospitalization

    Time frame: 30 days

    Number of subjects with heart failure 30-day hospitalization as reported by the sites

  7. Number of Deaths

    Time frame: One year

    Overall mortality rate for all subjects who started the trial is summarized.

  8. Change in Left Ventricular Ejection Fraction

    Time frame: baseline and one year

    Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)

  9. Change in Left Ventricular End Systolic Volume

    Time frame: baseline and one year

    Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: MPP-PMS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2016
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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