Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Terminated

• Conditions: Heart Failure, Unspecified
• Interventions: Other: Observational

• Registration Number: NCT03001141
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Study Start: 2017-05-18
• Primary Completion: 2018-04-18
• Study Completion: 2019-02-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group - observational	Observational	-

Primary Outcome Measures

Name	Time	Method
Cardiac resynchronization therapy response rate measured by Clinical Composite Score	12 months	Evaluated on regular medical visits and registered in the CRF

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Clinica Dom Rodrigo; 🇧🇷 João Pessoa, PB, Brazil

SEMAP; 🇧🇷 São Paulo, SP, Brazil

Instituto de Arritmias Cardíacas; 🇧🇷 São Paulo, SP, Brazil

BP; 🇧🇷 São Paulo, SP, Brazil