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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Resynchronization Therapy | Experimental | Patients implanted with a cardiac resynchronization therapy device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy | Device | All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SOCR Clinical Trial Leader | Medtronic CRHF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa Heart Center | Des Moines | Iowa | 50314-3017 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36574867 | Derived | Luo H, Westphal P, Shahmohammadi M, Heckman LIB, Kuiper M, Cornelussen RN, Delhaas T, Prinzen FW. Heart sound-derived systolic time intervals for atrioventricular delay optimization in cardiac resynchronization therapy. Heart Rhythm. 2023 Apr;20(4):572-579. doi: 10.1016/j.hrthm.2022.12.031. Epub 2022 Dec 24. |
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Eight patients exited the study prior to undergoing the research procedure: Four did not meet inclusion/exclusion criteria; In 2 cases, the physician deemed withdrawal medically necessary; and in 2 cases, the surgeon was unable to place the left ventricular (LV) lead.
Patient recruitment occurred from September 27, 2013 to January 28, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Resynchronization Therapy Patients | All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients undergoing the research procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Resynchronization Therapy Patients | All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest. | Posted | Number | participants | During implant |
|
During implant to 26 days post-implant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Patients | Adverse events were collected and are reported for all 50 enrolled patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Stimulation Issue | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medtronic SOCR Clinical Trial Leader | Medtronic CRHF | 1-800-328-2518 | medtronicCRMtrials@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| During implant |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Mercy Hospital Fairfield | Fairfield | Ohio | 45014 | United States |
| Victoria Cardiac Arrhythmia Trials | Victoria | British Columbia | V8R 4R2 | Canada |
| Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Quebec | GIV 4G5 | Canada |
| Grantham Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest. | Posted | Number | participants | During implant |
|
|
|
| Primary | 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 | Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest. | Posted | Number | participants | During implant |
|
|
|
| Primary | 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 | Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest. | Posted | Number | participants | During implant |
|
|
|
| 3 |
| 50 |
| 0 |
| 50 |
| Anaphylactic Shock | Immune system disorders | MedDRA (12.0) | Systematic Assessment | Allergic reaction to antibiotic |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
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