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Characterization of Interventricular Conduction Measurements

NCT ID: NCT01362465

Last Updated: 2012-09-20

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

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

Detailed Description

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The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cardiac Resynchronization Therapy (CRT)

Implanting device to measure delays between paced chambers in heart failure patients.

Group Type EXPERIMENTAL

Cardiac Resynchronization Therapy

Intervention Type PROCEDURE

Implanting device to measure delays between paced chambers in heart failure patients.

Interventions

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Cardiac Resynchronization Therapy

Implanting device to measure delays between paced chambers in heart failure patients.

Intervention Type PROCEDURE

Other Intervention Names

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CRT

Eligibility Criteria

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Inclusion Criteria

* Patient is greater than 18 years of age.
* The patient or the patient's legally authorized representative is willing to give informed consent.
* CRT indicated guidelines.
* Patient is receiving a Medtronic IPG or ICD.

Exclusion Criteria

* Patients who are pregnant.
* Patient is in AF.
* Patient with 3rd degree AV block.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brett Atwater, MD

Role: PRINCIPAL_INVESTIGATOR

Durham VA

Robert Hoyt, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic Health Initiative Iowa Corp

Eric E Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Sterns Cardiovascular Foundation

John F Beshai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Countries

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United States

Other Identifiers

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TDSICM

Identifier Type: -

Identifier Source: org_study_id