Congestive Heart FailureNCT01066078
Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)
An observational study of Congestive Heart Failure, run by LivaNova at 4 sites in France.
Trial summary
This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Echocardiography and SonR recording
- How many people
- 216 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2007to Oct 2009
- Phase
- Observational
- 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
Study population: CRT recipients
Who may be able to join
- Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.
Who cannot join
- Inability to understand the patient information sheet.
- Minor patient or pregnant woman.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Nouvelles Cliniques Nantaises
Nantes
Clinique Bizet
Paris, 75016
CHU Pontchaillou
Rennes
CHU Rennes
Rennes
About this study
Official title: Echocardiography and PEA Measurements in CRT Therapy
This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.
- Conditions
- Congestive Heart Failure
- Being tested
- Echocardiography and SonR recording
- Keywords
- heart failure - congestive, Cardiovascular imaging agents/Techniques], Echocardiography, Other diagnostic testing, Other Treatment, Recipients of cardiac resynchronization therapy systems
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and SonR recordingOther
| Study group | Role | What they receive |
|---|---|---|
| CRT recipients | Not described Receives: Other: Echocardiography and SonR recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR
Measured: 12 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 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erwan DONAL, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066078
- Sponsor's protocol ID
- RGEA01 - CAP PEA
- Other IDs
- RGEA01
- Status last verified
- Mar 2010
- First submitted
- 9 Feb 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography and PEA Measurements in CRT Therapy
- ClinicalTrials.gov ID
- NCT01066078
- Acronym / sponsor ID
- RGEA01 - CAP PEA
- Conditions
- Congestive Heart Failure
- Keywords
- heart failure - congestive, Cardiovascular imaging agents/Techniques], Echocardiography, Other diagnostic testing, Other Treatment, Recipients of cardiac resynchronization therapy systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Feb 2010 (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.
This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT recipients | – | Other: Echocardiography and SonR recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CRT recipients
Key inclusion criteria (1 listed)
- Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.
Key exclusion criteria (2 listed)
- Inability to understand the patient information sheet.
- Minor patient or pregnant woman.
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 |
|---|---|---|
| Echocardiography and SonR recording | Other | CRT recipients |
Primary outcome
The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR
Time frame: 12 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 5 Mar 2010.
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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.
Erwan DONAL, MD principal investigator
Rennes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by LivaNova at 4 sites in France.
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 1 inclusion and 2 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 5 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR (time frame: 12 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 5 Mar 2010; AzTrials last refreshed its copy on 8 Nov 2026.