Sensor Optimization of Cardiac Resynchronization Therapy Response

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Cardiac Resynchronization Therapy

• Registration Number: NCT01832493
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Study Start: 2013-07
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2016-07
• Results First Submitted: 2016-07-18
• Results First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Results First Posted: 2016-08-29
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Resynchronization Therapy	Cardiac Resynchronization Therapy	Patients implanted with a cardiac resynchronization therapy device

Primary Outcome Measures

Name	Time	Method
Optimal Electrode Configuration Determination Using Heart Sounds	During implant	Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max
AV Interval Determination Using Heart Sounds	During implant	Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max
AV Interval Determination Using Impedance	During implant	Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.
Optimal Electrode Configuration Determination Using Impedance	During implant	Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max

Trial Locations

Locations (9)

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

Mercy Hospital Fairfield; 🇺🇸 Fairfield, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada

Grantham Hospital; 🇭🇰 Hong Kong, Hong Kong

Kings College Hospital; 🇬🇧 London, United Kingdom

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Victoria Cardiac Arrhythmia Trials; 🇨🇦 Victoria, British Columbia, Canada