Heart FailurePhase 3NCT01169272
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
A Phase 3 study testing CRT-SonR 9770 in people with Heart Failure, run by LivaNova at 1 site in France.
Trial summary
Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization. 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?
- CRT-SonR 9770
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 3
- 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
- Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
- Implanted with atrial SonR lead
- Signed and dated informed consent
Who cannot join
- VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
- VF was caused by electrocution;
- Incessant VT/VF;
- Patient is unable to attend the scheduled follow-ups at the implanting centre;
- Patient is already enrolled in another ongoing clinical study;
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- Patient is unable to understand the aim of the study and its procedure;
- Patient refuses to cooperate;
- Patient is unable or refuses to provide informed consent;
- Patient is minor (less than 18-year old);
- Patient is pregnant;
- Patient has life expectancy of less than 1 year;
- Patient is forfeiture of freedom or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform
Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.
The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture.
The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.
Finally, the study will report the electrical and handling performances of the new left ventricular lead.
Read the detailed description
In this study, the sponsor aims at:
- Demonstrating the safety of the atrial SonR lead;
- Demonstrating the performances of the right ventricular autothreshold algorithm ;
- Reporting the adverse events documented in the study;
- Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
- Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances;
- Reporting the SonR atrial lead mechanical handling.
- Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization.
- Reporting the Situs 2 MV LV lead mechanical handling.
- Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.
- Conditions
- Heart Failure
- Being tested
- CRT-SonR 9770
- Keywords
- ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-SonR 9770Device
Also called 9770
Active implantable defibrillator with capacity of cardiac resynchronization therapy
| Study group | Role | What they receive |
|---|---|---|
| CRT-SonR 9770 | Experimental | Active implantable defibrillator with ability to cardiac resynchronization therapy Receives: Device: CRT-SonR 9770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the SonR lead safety
Complication free rate of the SonR lead superior to 90 %
Measured: 3 months
Secondary outcomes (7)
Incidence of adverse events
Any adverse will be documented thoughout the study and will be reported.
Measured: 12 months
ICD electrical performances
Report all ICD electrical performances of the Paradym RF ICD
Measured: 12 months
Evaluation of the SonR atrial lead performance
Report electrical performances and lead handling at implant
Measured: 3 months
Evaluation of the AV/VV delays optimization
Describe the performances of the manual and automatic AV/VV optimization algorithms. An optional daily life test could be performed to evaluate the automatic optimization at exercise.
Measured: 3 months
Evaluation of the left ventricular lead performances
Report the electrical performances and lead mechanical handling at implant.
Measured: 12 months
Evaluation of the Remote Monitoring Solution
Ensure the Home Monitor setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician.
Measured: 12 months
Evaluation of the right ventricular autothreshold performances
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2012
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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe CL Leclercq, Ryhtmologist, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169272
- Sponsor's protocol ID
- SonR Study - ITSY05
- Status last verified
- Jun 2014
- First submitted
- 20 Jul 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform
- ClinicalTrials.gov ID
- NCT01169272
- Acronym / sponsor ID
- SonR Study - ITSY05
- Conditions
- Heart Failure
- Keywords
- ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jul 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.
Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.
The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture.
The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.
Finally, the study will report the electrical and handling performances of the new left ventricular lead.
Detailed description
In this study, the sponsor aims at:
- Demonstrating the safety of the atrial SonR lead;
- Demonstrating the performances of the right ventricular autothreshold algorithm ;
- Reporting the adverse events documented in the study;
- Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
- Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances;
- Reporting the SonR atrial lead mechanical handling.
- Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization.
- Reporting the Situs 2 MV LV lead mechanical handling.
- Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT-SonR 9770 | Experimental | Device: CRT-SonR 9770Active implantable defibrillator with ability to cardiac resynchronization therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
- Implanted with atrial SonR lead
- Signed and dated informed consent
Key exclusion criteria (13 listed)
- VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
- VF was caused by electrocution;
- Incessant VT/VF;
- Patient is unable to attend the scheduled follow-ups at the implanting centre;
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 |
|---|---|---|
| CRT-SonR 9770Also: 9770Active implantable defibrillator with capacity of cardiac resynchronization therapy | Device | CRT-SonR 9770 |
Primary outcome
Evaluation of the SonR lead safety
Time frame: 3 months
Complication free rate of the SonR lead superior to 90 %
7 secondary outcomes
Incidence of adverse events
Time frame: 12 months
ICD electrical performances
Time frame: 12 months
Evaluation of the SonR atrial lead performance
Time frame: 3 months
Evaluation of the AV/VV delays optimization
Time frame: 3 months
Evaluation of the left ventricular lead performances
Time frame: 12 months
Evaluation of the Remote Monitoring Solution
Time frame: 12 months
Evaluation of the right ventricular autothreshold performances
Time frame: 1 month
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 18 Jun 2014.
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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.
Christophe CL Leclercq, Ryhtmologist principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CRT-SonR 9770 in people with Heart Failure, run by LivaNova at 1 site 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 3 inclusion and 13 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 18 Jun 2014. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the SonR lead safety (time frame: 3 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 Jun 2014.