Heart FailurePhase 4TUTORNCT01170624
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
A Phase 4 study testing ICD in people with Heart Failure, run by LivaNova at 25 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general… 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?
- ICD
- Type of treatment
- Medical device
- How many people
- 388 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 4
- 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 an ICD or a CRT-D device according to current available guidelines.
- Documented chronic HF (NYHA Class II to IV) at the time of enrollment
- Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
- Signed and dated informed consent
Who cannot join
- Any contraindication for ICD therapy
- Abdominal implantation site
- Acute myocarditis
- Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- Planned heart transplant
- Mechanical tricuspid valve
Show all 14Show fewer
- Unable to perform the 6 minute Walking Test at time of enrollment
- Already included in another clinical study
- Life expectancy less than 13 months
- Inability to understand the purpose of the study or refusal to cooperate
- Inability or refusal to provide informed consent
- Under guardianship
- Age of less than 18 years
- Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
France14 sites
Centre Hospitalier Général
Albi, 81013
Centre Hospitalier Universitaire D'Amiens
Amiens, 80090
Chu Annecy
Annecy, 74011
CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON
Avignon, 84000
Hopital D'Instruction Des Armees
Clamart, 92141
Hôpital St Joseph
Lyon, 69000
Centre Hospitalier Universitaire de La Timone
Marseille, 13000
Hopital Le Raincy Montfermeil
Montfermeil, 93370
HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie
Montpellier, 34295
Hopital de La Source
Orléans, 45067
Centre Hospitalier
Pau, 64000
CLINIQUE ST PIERRE Cardiologie
Perpignan, 66000
Ccn: Centre Cardiologique Du Nord St Denis
Saint-Denis, 93000
Chru Hôpital Trousseau
Tours, 37000
Germany5 sites
Kerckhoff Klinik Cardiology Department
Bad Nauheim, 61231
Lerckhoff Klinik
Bad Neuheim, 61231
Praxis Westend Studien GbR, Medianzentrum Haus 9
Berlin, 14050
Klinik Frankische Schweiz
Ebermannstadt, 91316 - 91320
Med. Univ. Klinik Lübeck
Lübeck, 23501 - 23570
Portugal3 sites
Hospital Garcia de Orta
Almada, 2801-951
Hospital de Santa Cruz - Carnaxide (Adragão)
Carnaxide, Lisbon District, 2795
Hospital Central Faro
Faro, 8000
Italy2 sites
Spedali Civili Divisione di Cardiologia
Brescia, 25123
Azienda Ospedaliera S. Croce E Carle
Cuneo, 12100
Belgium1 site
Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
Antwerp, 2020
About this study
Official title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.
Read the detailed description
The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.
- Conditions
- Heart Failure
- Being tested
- ICD
- Keywords
- PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective is to demonstrate that agreement correlation is superior to 67%
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs
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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170624
- Sponsor's protocol ID
- TUTOR - ITSY04
- Acronym
- TUTOR
- Status last verified
- Jan 2015
- First submitted
- 16 Jun 2010
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
- ClinicalTrials.gov ID
- NCT01170624
- Acronym / sponsor ID
- TUTOR / TUTOR - ITSY04
- Conditions
- Heart Failure
- Keywords
- PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs
- Enrolment
- 388 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 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.
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.
Detailed description
The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
- Documented chronic HF (NYHA Class II to IV) at the time of enrollment
- Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
- Signed and dated informed consent
Key exclusion criteria (14 listed)
- Any contraindication for ICD therapy
- Abdominal implantation site
- Acute myocarditis
- Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- Planned heart transplant
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 |
|---|---|---|
| ICDParadym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250 | Device | – |
Primary outcome
The objective is to demonstrate that agreement correlation is superior to 67%
Time frame: 13 months
Results and safety
The study was stopped early (reason given: Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICD in people with Heart Failure, run by LivaNova at 25 sites in 5 countries.
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 14 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: stopped early, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Germany, Portugal, Italy, Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs). Results are not available in the source record.
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 objective is to demonstrate that agreement correlation is superior to 67% (time frame: 13 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 12 Jan 2015.