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Sensor Optimization of Cardiac Resynchronization Therapy Response (SOCR)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iowa Heart Center
  • The Ohio State University
  • Mercy Hospital Fairfield
  • Victoria Cardiac Arrhythmia Trials
  • Ottawa Heart Institute
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Grantham Hospital
  • Queen Mary Hospital
  • Kings College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Resynchronization Therapy

Arm Description

Patients implanted with a cardiac resynchronization therapy device

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 20, 2013
Last Updated
July 18, 2016
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01832493
Brief Title
Sensor Optimization of Cardiac Resynchronization Therapy Response
Acronym
SOCR
Official Title
Sensor Optimization of CRT Response
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Resynchronization Therapy
Arm Type
Experimental
Arm Description
Patients implanted with a cardiac resynchronization therapy device
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy
Intervention Description
All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Primary Outcome Measure Information:
Title
AV Interval Determination Using Impedance
Description
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.
Time Frame
During implant
Title
AV Interval Determination Using Heart Sounds
Description
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
Time Frame
During implant
Title
Optimal Electrode Configuration Determination Using Impedance
Description
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
Time Frame
During implant
Title
Optimal Electrode Configuration Determination Using Heart Sounds
Description
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
Time Frame
During implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SOCR Clinical Trial Leader
Organizational Affiliation
Medtronic CRHF
Official's Role
Study Director
Facility Information:
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314-3017
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mercy Hospital Fairfield
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Victoria Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
GIV 4G5
Country
Canada
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensor Optimization of Cardiac Resynchronization Therapy Response

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