SOCR: Sensor Optimization of Cardiac Resynchronization Therapy Response

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01832493
• Collaborator: (none)
• Enrollment: 50
• Locations: 9
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Cardiac Resynchronization Therapy	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Primary Outcome Measures

1. 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.

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa Heart Center	Des Moines	Iowa	United States	50314-3017
2	The Ohio State University	Columbus	Ohio	United States	43210
3	Mercy Hospital Fairfield	Fairfield	Ohio	United States	45014
4	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia	Canada	V8R 4R2
5	Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
6	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec	Quebec	Canada	GIV 4G5
7	Grantham Hospital	Hong Kong		Hong Kong
8	Queen Mary Hospital	Hong Kong		Hong Kong
9	Kings College Hospital	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Director: SOCR Clinical Trial Leader, Medtronic CRHF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01832493
• Other Study ID Numbers: SOCR
• First Posted: Apr 16, 2013
• Last Update Posted: Aug 29, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	Patient recruitment occurred from September 27, 2013 to January 28, 2016.
Pre-assignment Detail	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.

Arm/Group Title	Cardiac Resynchronization Therapy Patients
Arm/Group Description	All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Period Title: Overall Study
STARTED	50
COMPLETED	42
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Cardiac Resynchronization Therapy Patients
Arm/Group Description	All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.1 (12.9)
Sex: Female, Male (Count of Participants)
Female	12 28.6%
Male	30 71.4%
Region of Enrollment (participants) [Number]
Canada	18 42.9%
United States	10 23.8%
United Kingdom	3 7.1%
Hong Kong	11 26.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.

Arm/Group Title	Cardiac Resynchronization Therapy
Arm/Group Description	Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Measure Participants	28
Number [participants]	14 33.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.

Arm/Group Title	Cardiac Resynchronization Therapy
Arm/Group Description	Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Measure Participants	26
Number [participants]	11 26.2%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.

Arm/Group Title	Cardiac Resynchronization Therapy
Arm/Group Description	Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Measure Participants	31
Number [participants]	8 19%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.

Arm/Group Title	Cardiac Resynchronization Therapy
Arm/Group Description	Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Measure Participants	28
Number [participants]	12 28.6%

Adverse Events

Time Frame	During implant to 26 days post-implant
Arm/Group Title	All Enrolled Patients
Arm/Group Description	Adverse events were collected and are reported for all 50 enrolled patients
All Cause Mortality
	All Enrolled Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Patients
	Affected / at Risk (%)	# Events
Total	3/50 (6%)
Cardiac disorders
Myocardial Infarction	1/50 (2%)	1
General disorders
Device Stimulation Issue	1/50 (2%)	1
Immune system disorders
Anaphylactic Shock	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	All Enrolled Patients
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.