N/A
Completed N=2,169
MultiPoint Pacing™ Post Market Study
Source: ClinicalTrials.gov NCT02832622 ↗Enrolled (actual)
2,169
Serious AEs
37.9%
Results posted
Feb 2021
Primary outcomePrimary: Number of CRT Responders as Measured by the Clinical Composite Score (CCS) — 350 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CRT Responders as Measured by the Clinical Composite Score (CCS) |
350 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02832622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.