Heart FailureSonR-ECHONCT01869062
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
A study testing SonR CRT Optimization 'On' and SonR CRT Optimization 'Off' in people with Heart Failure, run by MicroPort CRM at 1 site in Canada.
Trial summary
The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- SonR CRT Optimization 'On' and SonR CRT Optimization 'Off'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to 19 May 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines ;
- In Sinus Rhythm;
- Have reviewed, signed and dated an informed consent
Who cannot join
- Previous implant with a pacemaker, an Implantable Cardioverter-Defibrillator or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead not under recall or surveillance);
- Persistent atrial arrhythmias (or cardioversion for Atrial Fibrillation) within the past month;
- Ventricular tachyarrhythmia secondary to reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- Incessant ventricular tachyarrhythmia;
- Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 4 weeks;
- Correctable valvular disease that is the primary cause of heart failure;
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- Mechanical heart valve or indication for valve repair or replacement;
- Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
- Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
- Already included in another clinical study that could confound the results of this study;
- Life expectancy less than 1 year;
- Inability to understand the purpose of the study;
- Unavailability for scheduled follow-up or refusal to cooperate;
- Sensitivity to 1 mg Dexamethasone Sodium Phosphate (DSP);
- Age of less than 18 years;
- Pregnancy;
- Drug addiction or abuse;
- Under guardianship
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de Cardiologie et Pneumologie de Québec
Québec, G1V 4G5
About this study
The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.
This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.
Read the detailed description
This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to:
- Increase the rate of patients responding to CRT
- Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method.
The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp).
Patients will be considered as responders to CRT if their LVESV decreased by > 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms.
SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.
- Conditions
- Heart Failure
- Being tested
- SonR CRT Optimization 'On', SonR CRT Optimization 'Off'
- Keywords
- CRT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonR CRT Optimization 'On'Device
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
SonR CRT Optimization 'Off'Device
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
| Study group | Role | What they receive |
|---|---|---|
| SonR CRT Optimization 'On' | Other | CRT-D device with the SonR optimization algorithm programmed being 'on'. Receives: Device: SonR CRT Optimization 'On' |
| SonR CRT Optimization 'Off' | Other | CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). Receives: Device: SonR CRT Optimization 'Off' |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT-responders rate increase based on LVESV decrease at M6 / baseline
For the purpose of this study, CRT-responders are defined as patients experiencing a decrease in LVESV of 15% or more at M6 Fup as most clinical trials used.
The main objective of the SONR-ECHO trial is to show a minimum increase of CRT-responders rate of 15% (up to 72% or more) in the SonR study group as compared to SoC arm.
Measured: 6 months
Secondary outcomes (1)
A-wave truncation assessment at M6
The Ritter's method attempts to optimize AV and VV timings in dual-chamber PM patients. According to this method, AV delay is optimal when LVFT is maximal and mitral valve closure only occurs after atrial systole (A-wave) is complete.
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 posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion19 May 2016
- Study completion19 May 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CRT-D device
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Philippon, Principal investigator, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869062
- Sponsor's protocol ID
- ICSY01
- Acronym
- SonR-ECHO
- Status last verified
- Mar 2019
- First submitted
- 27 May 2013
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
- ClinicalTrials.gov ID
- NCT01869062
- Acronym / sponsor ID
- SonR-ECHO / ICSY01
- Conditions
- Heart Failure
- Keywords
- CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 5 Jun 2013 (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 main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.
This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.
Detailed description
This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to:
- Increase the rate of patients responding to CRT
- Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method.
The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp).
Patients will be considered as responders to CRT if their LVESV decreased by > 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms.
SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- CRT-D device
| Arm | Type | Receives |
|---|---|---|
| SonR CRT Optimization 'On' | Other | Device: SonR CRT Optimization 'On'CRT-D device with the SonR optimization algorithm programmed being 'on'. |
| SonR CRT Optimization 'Off' | Other | Device: SonR CRT Optimization 'Off'CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines ;
- In Sinus Rhythm;
- Have reviewed, signed and dated an informed consent
Key exclusion criteria (18 listed)
- Previous implant with a pacemaker, an Implantable Cardioverter-Defibrillator or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead not under recall or surveillance);
- Persistent atrial arrhythmias (or cardioversion for Atrial Fibrillation) within the past month;
- Ventricular tachyarrhythmia secondary to reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- Incessant ventricular tachyarrhythmia;
- Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 4 weeks;
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 |
|---|---|---|
| SonR CRT Optimization 'On'Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'. | Device | SonR CRT Optimization 'On' |
| SonR CRT Optimization 'Off'Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). | Device | SonR CRT Optimization 'Off' |
Primary outcome
CRT-responders rate increase based on LVESV decrease at M6 / baseline
Time frame: 6 months
For the purpose of this study, CRT-responders are defined as patients experiencing a decrease in LVESV of 15% or more at M6 Fup as most clinical trials used. The main objective of the SONR-ECHO trial is to show a minimum increase of CRT-responders rate of 15% (up to 72% or more) in the SonR study group as compared to SoC arm.
1 secondary outcome
A-wave truncation assessment at M6
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
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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.
François Philippon principal investigator
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonR CRT Optimization 'On' and SonR CRT Optimization 'Off' in people with Heart Failure, run by MicroPort CRM at 1 site in Canada.
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 3 inclusion and 18 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 22 Mar 2019. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CRT-responders rate increase based on LVESV decrease at M6 / baseline (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 22 Mar 2019.