NCT02832622

MultiPoint Pacing™ Post Market Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,169 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2016-07-14
• Last updated: 2021-02-17
• Results posted: 2021-02-17

Locations

128 sites across 4 countries: United States, Argentina, Colombia, Japan