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Completed

NCT Number: NCT01832493

Sensor Optimization of Cardiac Resynchronization Therapy 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac resynchronization therapy

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Sensor Optimization of CRT Response

Acronym: SOCR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2013
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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