Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-18

Study Completion Date

2019-02-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single group - observational

Observational

Intervention Type OTHER

Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.

Interventions

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Observational

Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No