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Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal

NCT ID: NCT01287234

Last Updated: 2012-12-20

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

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.

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

Blinding Strategy

NONE

Study Groups

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All Patients

All patients will have an echocardiogram and SonR sensor readings completed.

Group Type OTHER

Echocardiogram/SonR

Intervention Type OTHER

All patients will have an echocardiograph and SonR sensor readings

Interventions

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Echocardiogram/SonR

All patients will have an echocardiograph and SonR sensor readings

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
* ≥18 years of age
* Ability and willingness to provide written informed consent and HIPAA authorization

Exclusion Criteria

* Chronic Atrial Fibrillation
* Heart Failure decompensation event within two weeks of enrollment
* Hypertrophic Obstructive Cardiomyopathy
* Patient currently enrolled in another ongoing clinical trial
* Pregnancy
* Less than 18 years of age
* Inability or unwillingness to provide written informed consent and HIPAA authorization
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 Pilot

Identifier Type: -

Identifier Source: org_study_id