Heart FailureSonR AccessNCT01293526
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR
A study testing Experimental and Experimental 2 in people with Heart Failure, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart. 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?
- Experimental and Experimental 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
- Indicated for CRT according to current guidelines
- QRS Duration between 120 ms and 150 ms
- Able and willing to provide consent and Authorization of Use of PHI
Who cannot join
- Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
- Planned, or recent heart surgery or revascularization within the last three months
- Already enrolled in other study that precludes enrollment in this study per Principal Investigator
- Known Pregnancy at the time of enrollment
- Age less than 18 at the time of enrollment
- Unable to comply with follow-up requirements
Show all 9Show fewer
- Chronic Atrial Fibrillation
- Recent history of medical non-compliance as determined by the investigator
- Unable or unwilling to provide consent and Authorization of Use of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR
The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
Read the detailed description
A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.
Group 1: Patients with no response
Patients with a successful response will be randomized to:
Group 2: Lead placement based on study measurements
OR
Group 3: Standard lead placement
- Conditions
- Heart Failure
- Being tested
- Control, Experimental, Experimental 2
- Keywords
- Heart failure, echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
Patients who respond will have leads will be placed using standard procedures.
ExperimentalDevice
Patients who respond will have their leads placed based on study measurements.
Experimental 2Device
Patients who respond will have their leads placed based on standard lead placement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Patients who respond will have their leads placed based on study measurements. Receives: Device: Experimental |
| Control | Experimental | Leads will be placed using standard procedures. Receives: Device: Control |
| Experimental 2 | Experimental | Patients who respond will have their leads placed based on standard lead placement. Receives: Device: Experimental 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of responding patients
Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.
Measured: 6 months
Secondary outcomes (1)
Comparison of echocardiography and SonR signals
Correlation of the results of optimization performed by echocardiography with the optimal setting as defined by the SonR signal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: PI left institution, no replacement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Responsible party
- Sponsor
- Investigators
- Dan Dan, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293526
- Sponsor's protocol ID
- SonR Access
- Acronym
- SonR Access
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2011
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR
- ClinicalTrials.gov ID
- NCT01293526
- Acronym / sponsor ID
- SonR Access / SonR Access
- Conditions
- Heart Failure
- Keywords
- Heart failure, echocardiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution, no replacement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- Feb 2011 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
Detailed description
A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.
Group 1: Patients with no response
Patients with a successful response will be randomized to:
Group 2: Lead placement based on study measurements
OR
Group 3: Standard lead placement
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Device: ExperimentalPatients who respond will have their leads placed based on study measurements. |
| Control | Experimental | Device: ControlLeads will be placed using standard procedures. |
| Experimental 2 | Experimental | Device: Experimental 2Patients who respond will have their leads placed based on standard lead placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
- Indicated for CRT according to current guidelines
- QRS Duration between 120 ms and 150 ms
- Able and willing to provide consent and Authorization of Use of PHI
Key exclusion criteria (9 listed)
- Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
- Planned, or recent heart surgery or revascularization within the last three months
- Already enrolled in other study that precludes enrollment in this study per Principal Investigator
- Known Pregnancy at the time of enrollment
- Age less than 18 at the time of enrollment
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 |
|---|---|---|
| ControlPatients who respond will have leads will be placed using standard procedures. | Device | Control |
| ExperimentalPatients who respond will have their leads placed based on study measurements. | Device | Experimental 1 |
| Experimental 2Patients who respond will have their leads placed based on standard lead placement. | Device | Experimental 2 |
Primary outcome
Percent of responding patients
Time frame: 6 months
Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.
1 secondary outcome
Comparison of echocardiography and SonR signals
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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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.
Dan Dan, MD principal investigator
Piedmont Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Experimental 2 in people with Heart Failure, run by Piedmont Healthcare at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent of responding patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.