Heart FailurePhase 3CLEPSYDRANCT02167789
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
A Phase 3 study testing Paradym CRT 8770 in people with Heart Failure, run by LivaNova at 50 sites in 9 countries.
Trial summary
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD). 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?
- Paradym CRT 8770
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 50 sitesin 9 countries
- Study dates
- Sep 2009to Jun 2013
- 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-D device according to current available guidelines for cardiac resynchronization therapy
- Severe HF (NYHA Class III or IV) at the time of enrollment
- At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
- Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
- Scheduled for implant of a PARADYM 8770
- Signed and dated informed consent
Who cannot join
- Any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Abdominal implantation side
- Hypertrophic or obstructive cardiomyopathy
- Acute myocarditis
- Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
Show all 21Show fewer
- Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
- Correctable valvular disease that is the primary cause of heart failure
- Mechanical tricuspid valve
- Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
- Heart transplant recipient
- Renal insufficiency requiring dialysis
- Already included in another clinical study
- Life expectancy less than 12 months
- Inability to understand the purpose of the study or refusal to cooperate
- Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
- Unavailability for scheduled follow-up at the implanting center
- Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
- 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
50 sites in 9 countries.
50 sites in 9 countries
France15 sites
Dr. Dupuis
Angers, Angers, 49033
Dr. Defaye
Grenoble, Grenoble, 38043
Dr. Bru
La Rochelle, La Rochelle, 17019
Pr. Kacet
Lille, Lille, 59037
Dr. Pisapia
Marseille, Marseille, 13008
Pr. Davy
Montpellier, Montpellier, 34000
Dr. Burban
Nantes, Nantes, 44000
Dr Abbey
Nantes, Nantes, 44093
Dr. Jauvert
Paris, 75016
Dr. Ritter
Pessac, Pessac, 33604
Pr. Mabo
Rennes, Rennes, 35033
Pr. Anselme
Rouen, Rouen, 76031
Pr. Da Costa
Saint-Etienne, Saint Etienne, 42055
Dr. Delay
Toulouse, Toulouse, 31059
Pr. Sadoul
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500
Germany14 sites
Dr. Sperzel
Bad Nauheim, Bad Nauheim, D-61231
Dr. Vogt
Bad Oeynhausen, Bad Oeynhausen, D-32545
Dr. Fleck - Dr. Goetze
Berlin, State of Berlin, 13353
Dr. Schlegl
Berlin, State of Berlin, 14050
Dr. Butter
Bernau, Bernau, 16321
Pr. Brachmann
Coburg, Coburg, D-48149
Dr. Klein - Dr. Oswald
Hanover, Hannover, 30625
Pr. Bauer
Heidelberg, Heidelberg, 69120
Pr. Mewis - Pr. Fröhlig
Homburg, Homburg, D-66421
Dr. Wieckhorst
Kiel, Kiel, 24105
Dr. Bonnemeier
Lübeck, Lübeck, D-23538
Pr. Weiss
Lüneburg, Lüneburg, 21339
Dr. Kolb
München, Munchen, 80636
Pr. Eckhardt
Münster, Münster, D-48149
United Kingdom6 sites
Dr. Leyva
Birmingham, Birmingham, B75 7RR
Dr Fluck - Dr. Beeton
Chertsey, Chertsey, KT160PZ
Dr. NG
Leicester, Leicester, LE3 9PQ
Dr. Murgatroyd
London, London, WC2R 2LS
Dr. Bowes
Sheffield, Sheffield, S5 7AU
Dr. Morgan
Southampton, Southampton, SO16 9YD
United States5 sites
Drs. Jagmeet Singh, Kevin, Hiest
Boston, Massachusetts
Dr. Gold
Charleston, South Carolina
Dr. Haines
Kaplan, Phoenix,, Arizona
Drs. John Fisher, Jay Gross
Montefiore, Bronx NY, New York
Drs. Lewis, Garg
Siegel, Phoenix,, Arizona
Spain4 sites
Dr. Martinez
Alicante, Alicante, 03010
Dr. Brugada
Barcelona, Barcelona, 08036
Dr. Peinado
Madrid, Madrid, 28046
Dr. Beiras
Vigo, Vigo, 3204
Canada2 sites
Dr. Champagne, Dr. Philippon
Québec, Quebec, G1V 4G5
Drs. Thibualt, Guerra
Québec, Quebec, H1T 1C8
Italy2 sites
Dr. Leonardo Calo
Roma, Roma, 00169
Dr Mantovan
Treviso, Treviso, 31100
About this study
Official title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
Read the detailed description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
- Conditions
- Heart Failure
- Being tested
- Paradym CRT 8770
- Keywords
- HF, diagnosis
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paradym CRT 8770Device
| Study group | Role | What they receive |
|---|---|---|
| PhD | No intervention | Not described Receives: Device: Paradym CRT 8770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HF related events
Measured: 13 months
Secondary outcomes (1)
Co morbidities
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 posted19 Jun 2014 (estimated)
- Study startSep 2009
- Primary completionJun 2013
- Study completionJun 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167789
- Sponsor's protocol ID
- ITSY02
- Acronym
- CLEPSYDRA
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
- ClinicalTrials.gov ID
- NCT02167789
- Acronym / sponsor ID
- CLEPSYDRA / ITSY02
- Conditions
- Heart Failure
- Keywords
- HF, diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Jun 2014 (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 clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
Detailed description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PhD | No intervention | Device: Paradym CRT 8770 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- Severe HF (NYHA Class III or IV) at the time of enrollment
- At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
- Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
- Scheduled for implant of a PARADYM 8770
Key exclusion criteria (21 listed)
- Any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Abdominal implantation side
- Hypertrophic or obstructive cardiomyopathy
- Acute myocarditis
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 |
|---|---|---|
| Paradym CRT 8770 | Device | PhD |
Primary outcome
Number of HF related events
Time frame: 13 months
1 secondary outcome
Co morbidities
Time frame: 13 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 19 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.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paradym CRT 8770 in people with Heart Failure, run by LivaNova at 50 sites in 9 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 6 inclusion and 21 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 19 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 50 sites in France, Germany, United Kingdom, United States, Spain and 4 more countries. 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?
Number of HF related events (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 19 Jun 2014.