Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Abbott

Status: Terminated

Conditions: Heart Failure, Unspecified

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT03001141

U1111-1190-5280

Details and patient eligibility

About

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.

Full description

Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study.

Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient willing and able to sign Informed Consent Form
• Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability

Exclusion criteria

• Is likely to undergo a heart transplantation within 12 months
• Is less than 18 years old
• Is pregnant or is planning to get pregnant during the study
• Is currently taking part in a Clinical Trial with an active treatment group
• Life expectancy is under 6 months

Trial design

200 participants in 1 patient group

Single group - observational

Treatment:

Other: Observational