Heart FailureORPHEENCT03127202
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
A study testing Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) in people with Heart Failure, run by LivaNova at 12 sites in France.
Trial summary
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation. 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 -Defibrillator (range PARADYM, LivaNova, Clamart, France)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 12 sitesFrance
- Study dates
- Nov 2012to Dec 2015
- 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
- Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)
- Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator
- Patient has given his informed consent
Who cannot join
- Any contraindication for Implantable Cardioverter Defibrillator therapy
- Heart transplantation or waiting for heart transplantation
- Implanted with a ventricular assist device (VAD)
- Inability to understand the purpose of the study or to cooperate
- Not available for routine follow-up visits
- Life expectancy less than 12 months
- Age of less than 18 years and et pregnancy
- Under guardianship
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CH Annecy
Annecy
Hopital Henri Mondor
Créteil
CH LENS
Lens, 62307
CH de Bretagne Sud
Lorient, 56322
Clinique Clairval
Marseille, 13000
CHP Beauregard
Marseille, 13012
Clinique Montpellier
Montpellier
Polyclinique de Gentilly
Nancy, 54100
CHU Groupe Hospitalo-universitaire Caremeau
Nîmes, 30029
Hopital de La Source
Orléans, 45067
CH St Joseph
Paris
Clinique St Pierre
Perpignan
About this study
Official title: Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
Read the detailed description
The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.
Success was defined as an absence of phrenic nerve stimulation (threshold > 7V) or in case of phrenic nerve stimulation occurrence (threshold < 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.
Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
- Keywords
- 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 Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)Device
Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Resynchronization Therapy-Defibrillator | Experimental | Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator Receives: Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phrenic nerve stimulation measurement
The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer
Measured: The presence of phrenic nerve stimulation will be assessed at implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henri BENKEMOUN, Principal investigator, Clinique Saint Pierre - Perpignan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127202
- Sponsor's protocol ID
- RTSY01
- Acronym
- ORPHEE
- Status last verified
- Apr 2017
- First submitted
- 2 Mar 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
- ClinicalTrials.gov ID
- NCT03127202
- Acronym / sponsor ID
- ORPHEE / RTSY01
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
Detailed description
The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.
Success was defined as an absence of phrenic nerve stimulation (threshold > 7V) or in case of phrenic nerve stimulation occurrence (threshold < 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.
Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Resynchronization Therapy-Defibrillator | Experimental | Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)
- Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator
- Patient has given his informed consent
Key exclusion criteria (8 listed)
- Any contraindication for Implantable Cardioverter Defibrillator therapy
- Heart transplantation or waiting for heart transplantation
- Implanted with a ventricular assist device (VAD)
- Inability to understand the purpose of the study or to cooperate
- Not available for routine follow-up visits
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 Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion. | Device | Cardiac Resynchronization Therapy-Defibrillator |
Primary outcome
Phrenic nerve stimulation measurement
Time frame: The presence of phrenic nerve stimulation will be assessed at implant.
The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer
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 25 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Henri BENKEMOUN principal investigator
Clinique Saint Pierre - Perpignan
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) in people with Heart Failure, run by LivaNova at 12 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 3 inclusion and 8 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Phrenic nerve stimulation measurement (time frame: The presence of phrenic nerve stimulation will be assessed at implant.). 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 25 Apr 2017.