Study Protocol/ Registry of MultiPoint™ Pacing in Brazil | NCT03001141

Studies
Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

NCT03001141

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Sep 16, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Heart Failure, Unspecified

Interventions

Observational

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Ethic Comitte (CONEP) determinated the prematurely terminated.

Expanded Access Info

Start Date

May 18, 2017Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

Feb 8, 2019Actual

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Dec 20, 2016

First Posted Date

Dec 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2019

Last Update Posted Date

Sep 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single group - observational			Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.	Single group - observational

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Aurelio Santos	Abbott Medical Devices	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Dom Rodrigo		João Pessoa	Paraíba		Brazil
BP

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006333	Heart Failure

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

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