MultiPoint Pacing™ Post Market Study (MPP-PMS)

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: MPP; Device: BiV/MPP

Study type: Observational

Funder types: Industry

Identifiers

NCT02832622

SJM-CIP-10149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,169 participants in 1 patient group

MPP Programming

Description:

This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.

Treatment:

Device: BiV/MPP

Device: MPP