Heart Failure
Conditions
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.
Interventions
DEVICECardiac Resynchronization Therapy
All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AV Interval Determination Using Impedance | 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. |
| AV Interval Determination Using Heart Sounds | 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 |
| Optimal Electrode Configuration Determination Using Impedance | 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 |
| Optimal Electrode Configuration Determination Using Heart Sounds | 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 |
Countries
Canada, Hong Kong, United Kingdom, United States
Participant flow
Recruitment details
Patient recruitment occurred from September 27, 2013 to January 28, 2016.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Resynchronization Therapy Patients All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Unable to place LV lead | 2 |
Baseline characteristics
| Characteristic | Cardiac Resynchronization Therapy Patients |
|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Canada | 18 participants |
| Region of Enrollment Hong Kong | 11 participants |
| Region of Enrollment United Kingdom | 3 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
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
Time frame: During implant
Population: Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy | AV Interval Determination Using Heart Sounds | 11 participants |
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.
Time frame: During implant
Population: Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy | AV Interval Determination Using Impedance | 14 participants |
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
Time frame: During implant
Population: Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy | Optimal Electrode Configuration Determination Using Heart Sounds | 12 participants |
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
Time frame: During implant
Population: Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy | Optimal Electrode Configuration Determination Using Impedance | 8 participants |