Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

NCT03001141 | Terminated

• 1 other identifier: U1111-1190-5280
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure, Unspecified

Keywords

MultiPoint Pacing; Heart Failure; Cardiac Resynchronization Therapy; Quadripolar pacing

Outcome Measures

Primary Outcomes (1)

• Cardiac resynchronization therapy response rate measured by Clinical Composite Score

  Evaluated on regular medical visits and registered in the CRF

  12 months

Secondary Outcomes (7)

• Quality of Life changes, measured by MLWHF questionnaire

  12 months

• Quality of Life changes, measured by EQ-5D questionnaire

  12 months

• Change in left ventricular ejection fraction

  12 months

• Change in left ventricular end systolic volume

  12 months

• Programming strategy used (vector and intervals), obtained from the Device Session records

  12 months

Study Arms (1)

Single group - observational

Other: Observational

Interventions

Observational OTHER

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

Single group - observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (4)

Clinica Dom Rodrigo

João Pessoa, Paraíba, Brazil

Location

BP

São Paulo, São Paulo, 01323-001, Brazil

Location

Instituto de Arritmias Cardíacas

São Paulo, São Paulo, 01323-001, Brazil

Location

SEMAP

São Paulo, São Paulo, 04.004-030, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Marco Aurelio Santos

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: May 18, 2017
• Primary Completion: April 18, 2018
• Study Completion: February 8, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

BR (4)