Sensor Optimization of Cardiac Resynchronization Therapy Response

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-06-30

Brief Summary

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The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.

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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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Cardiac Resynchronization Therapy

Patients implanted with a cardiac resynchronization therapy device

Group Type EXPERIMENTAL

Cardiac Resynchronization Therapy

Intervention Type DEVICE

All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.

Interventions

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Cardiac Resynchronization Therapy

All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
* Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
* Subject (or subject's legally authorized representative) must be willing to give informed consent
* Subjects must be at least 18 years of age

Exclusion Criteria

* Subject has congenital heart disease
* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
* Subject has unstable coronary artery disease
* Subject cannot undergo transvenous catheterization
* Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
* Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
* Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
* Subject is pregnant
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No