MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

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

2014-03-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MultiPoint Pacing

CRT with MultiPoint Pacing

Group Type EXPERIMENTAL

CRT with MultiPoint Pacing

Intervention Type DEVICE

Hemodynamic measurements for CRT device programming

Intervention Type PROCEDURE

Interventions

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CRT with MultiPoint Pacing

Intervention Type DEVICE

Hemodynamic measurements for CRT device programming

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
* Be in NYHA II or III functional class 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 persistent or permanent atrial fibrillation
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be scheduled or considered for heart transplantation over the next 12 months
* Be less than 18 years of age
* Be pregnant or plan to become pregnant over the next 12 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No