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Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR

NCT ID: NCT01293526

Last Updated: 2024-12-18

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

Detailed Description

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A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.

Group 1: Patients with no response

Patients with a successful response will be randomized to:

Group 2: Lead placement based on study measurements

OR

Group 3: Standard lead placement

Conditions

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Heart Failure

Keywords

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Heart failure echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental 1

Patients who respond will have their leads placed based on study measurements.

Group Type EXPERIMENTAL

Experimental

Intervention Type DEVICE

Patients who respond will have their leads placed based on study measurements.

Control

Leads will be placed using standard procedures.

Group Type EXPERIMENTAL

Control

Intervention Type DEVICE

Patients who respond will have leads will be placed using standard procedures.

Experimental 2

Patients who respond will have their leads placed based on standard lead placement.

Group Type EXPERIMENTAL

Experimental 2

Intervention Type DEVICE

Patients who respond will have their leads placed based on standard lead placement.

Interventions

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Control

Patients who respond will have leads will be placed using standard procedures.

Intervention Type DEVICE

Experimental

Patients who respond will have their leads placed based on study measurements.

Intervention Type DEVICE

Experimental 2

Patients who respond will have their leads placed based on standard lead placement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
* Indicated for CRT according to current guidelines
* QRS Duration between 120 ms and 150 ms
* Able and willing to provide consent and Authorization of Use of PHI

Exclusion Criteria

* Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
* Planned, or recent heart surgery or revascularization within the last three months
* Already enrolled in other study that precludes enrollment in this study per Principal Investigator
* Known Pregnancy at the time of enrollment
* Age less than 18 at the time of enrollment
* Unable to comply with follow-up requirements
* Chronic Atrial Fibrillation
* Recent history of medical non-compliance as determined by the investigator
* Unable or unwilling to provide consent and Authorization of Use of PHI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LivaNova

INDUSTRY

Sponsor Role collaborator

Piedmont Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Dan, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Locations

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Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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SonR Access

Identifier Type: -

Identifier Source: org_study_id