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Sensor Optimization of Cardiac Resynchronization Therapy Response (SOCR)

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ClinicalTrials.gov Identifier: NCT01832493
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Cardiac Resynchronization Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensor Optimization of CRT Response
Study Start Date : July 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. AV Interval Determination Using Impedance [ Time Frame: 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.

  2. AV Interval Determination Using Heart Sounds [ Time Frame: 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

  3. Optimal Electrode Configuration Determination Using Impedance [ Time Frame: 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

  4. Optimal Electrode Configuration Determination Using Heart Sounds [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832493


Locations
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United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314-3017
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Mercy Hospital Fairfield
Fairfield, Ohio, United States, 45014
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, GIV 4G5
Hong Kong
Grantham Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
United Kingdom
Kings College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Director: SOCR Clinical Trial Leader Medtronic CRHF
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01832493    
Other Study ID Numbers: SOCR
First Posted: April 16, 2013    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: August 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases