Sensor Optimization of Cardiac Resynchronization Therapy Response (SOCR)

Sensor Optimization of CRT Response

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Victoria Cardiac Arrhythmia Trials
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Ottawa Heart Institute
  • Quebec
    • Québec, Quebec, Canada, GIV 4G5
      • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Grantham Hospital
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314-3017
      • Iowa Heart Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Fairfield, Ohio, United States, 45014
      • Mercy Hospital Fairfield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Resynchronization Therapy; Patients implanted with a cardiac resynchronization therapy device	Device: Cardiac Resynchronization Therapy; All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AV Interval Determination Using Impedance	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.	During implant
AV Interval Determination Using Heart Sounds	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	During implant
Optimal Electrode Configuration Determination Using Impedance	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	During implant
Optimal Electrode Configuration Determination Using Heart Sounds	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	During implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: SOCR Clinical Trial Leader, Medtronic CRHF

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SOCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No