MPP Programming Study

NCT ID: NCT01856725

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MultiPoint Pacing programming based on hemodynamics

CRT device implant with MultiPoint Pacing

Hemodynamic measurements for CRT device programming

Group Type ACTIVE_COMPARATOR

Hemodynamic measurements for CRT device programming

Intervention Type PROCEDURE

CRT device implant with MultiPoint Pacing

Intervention Type DEVICE

MultiPoint Pacing programming without hemodynamics

CRT device implant with MultiPoint Pacing

CRT device programming without hemodynamics

Group Type EXPERIMENTAL

CRT device implant with MultiPoint Pacing

Intervention Type DEVICE

Interventions

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Hemodynamic measurements for CRT device programming

Intervention Type PROCEDURE

CRT device implant with MultiPoint Pacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria

* Have high ventricular rate (\>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
* Be in NYHA IV functional class
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be less than 18 years of age
* Be pregnant or planning to become pregnant during the duration of the investigation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlo Pappone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital, GVM Care & Research

Locations

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Maria Cecilia Hospital, GVM Care & Research

Cotignola, RA, Italy

Site Status

Countries

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Italy

Other Identifiers

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CRD_684

Identifier Type: -

Identifier Source: org_study_id

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