Heart FailureSOCRNCT01832493
Sensor Optimization of Cardiac Resynchronization Therapy Response
A study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jul 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States3 sites
The Ohio State University
Columbus, Ohio, 43210
Iowa Heart Center
Des Moines, Iowa, 50314-3017
Mercy Hospital Fairfield
Fairfield, Ohio, 45014
Canada3 sites
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, GIV 4G5
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8R 4R2
About this study
Official title: Sensor Optimization of CRT 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.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Resynchronization Therapy | Experimental | Patients implanted with a cardiac resynchronization therapy device Receives: Device: Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: During implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SOCR Clinical Trial Leader, Study director, Medtronic CRHF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832493
- Sponsor's protocol ID
- SOCR
- Acronym
- SOCR
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2013
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36574867
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Optimization of CRT Response
- ClinicalTrials.gov ID
- NCT01832493
- Acronym / sponsor ID
- SOCR / SOCR
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 29 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Resynchronization Therapy | Experimental | Device: Cardiac Resynchronization TherapyPatients implanted with a cardiac resynchronization therapy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization TherapyAll study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods. | Device | Cardiac Resynchronization Therapy |
Primary outcome
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.
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36574867Luo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SOCR Clinical Trial Leader study director
Medtronic CRHF
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, Hong Kong, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AV Interval Determination Using Impedance (time frame: During implant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.