Clinical trial NCT03001141: Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
Official title: Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure, Unspecified
Keywords: MultiPoint Pacing
Heart Failure
Cardiac Resynchronization Therapy
Quadripolar pacing
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac resynchronization therapy response rate measured by Clinical Composite Score
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life changes, measured by MLWHF questionnaire
timeFrame: 12 months
measure: Quality of Life changes, measured by EQ-5D questionnaire
timeFrame: 12 months
measure: Change in left ventricular ejection fraction
timeFrame: 12 months
measure: Change in left ventricular end systolic volume
timeFrame: 12 months
measure: Programming strategy used (vector and intervals), obtained from the Device Session records
timeFrame: 12 months
measure: Heart failure hospitalization rate
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Clinica Dom Rodrigo
state: PB
city: São Paulo
country: Brazil
facility: BP
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Arritmias Cardíacas
state: SP
city: São Paulo
country: Brazil
facility: SEMAP
state: SP
Study officials:
affiliation: Abbott Medical Devices
name: Marco Aurelio Santos
role: STUDY_DIRECTOR
References: