Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Study Overview
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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.

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.

Official Title
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Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Conditions
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Heart Failure, Unspecified

Intervention / Treatment
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* Other: Observational


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group - observational<br> | Other: Observational<br>* Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac resynchronization therapy response rate measured by Clinical Composite Score | Evaluated on regular medical visits and registered in the CRF | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life changes, measured by MLWHF questionnaire | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| Quality of Life changes, measured by EQ-5D questionnaire | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| Change in left ventricular ejection fraction | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| Change in left ventricular end systolic volume | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| Programming strategy used (vector and intervals), obtained from the Device Session records | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| Heart failure hospitalization rate | Evaluated on regular medical visits and registered in the CRF | 12 months | 
| All-cause mortality | Evaluated on regular medical visits and registered in the CRF | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, Quadripolar pacing