Congestive Heart FailurePhase 2CLEPSYDRANCT00957541
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
A Phase 2 study testing Paradym CRT + Physiological Diagnosis (PhD) in people with Congestive Heart Failure, run by ELA Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. 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?
- Paradym CRT + Physiological Diagnosis (PhD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2013
- Phase
- Phase 2
- 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
- Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- Subject has severe heart failure (NYHA Class III or IV)
- Subject has experienced at least one heart failure event within six months prior to enrollment
- Subject continues to have heart failure symptoms despite receiving optimal medical therapy
- Schedule for implant of a PARADYM CRT-D (Model 8770)
- Subject has signed and dated an informed consent form
Who cannot join
- Any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Abdominal implantation site
- 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 (intravenous 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 or HIPAA
- Unavailability for scheduled follow-up at the implanting center
- Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
- Under guardianship
- Age of less than 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
Read the detailed description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.
- Conditions
- Congestive Heart Failure
- Being tested
- Paradym CRT + Physiological Diagnosis (PhD)
- Keywords
- NYHA Class III or IV, Implantable Cardiac Defibrillator, 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.
Paradym CRT + Physiological Diagnosis (PhD)Device
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
| Study group | Role | What they receive |
|---|---|---|
| CRT Therapy | Experimental | All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled. Receives: Device: Paradym CRT + Physiological Diagnosis (PhD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
Measured: Thirteen months
Mean number of false positives per patient per year.
Measured: Thirteen Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LivaNova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957541
- Sponsor's protocol ID
- ITSY02
- Acronym
- CLEPSYDRA
- Status last verified
- May 2014
- First submitted
- 10 Aug 2009
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Auricchio A, Brugada J, Ellenbogen KA, Gold MR, Leyva F; CLEPSYDRA investigators. Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study. Eur J Heart Fail. 2010 Dec;12(12):1363-71. doi: 10.1093/eurjhf/hfq170. Epub 2010 Oct 14.
PubMed 20947571
Study at a glance
From the registry record, last updated by the sponsor on 15 May 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 Device
- ClinicalTrials.gov ID
- NCT00957541
- Acronym / sponsor ID
- CLEPSYDRA / ITSY02
- Conditions
- Congestive Heart Failure
- Keywords
- NYHA Class III or IV, Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- ELA Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- LivaNova
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Aug 2009 (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 a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
Detailed description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT Therapy | Experimental | Device: Paradym CRT + Physiological Diagnosis (PhD)All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- Subject has severe heart failure (NYHA Class III or IV)
- Subject has experienced at least one heart failure event within six months prior to enrollment
- Subject continues to have heart failure symptoms despite receiving optimal medical therapy
- Schedule for implant of a PARADYM CRT-D (Model 8770)
Key exclusion criteria (21 listed)
- Any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Abdominal implantation site
- 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 + Physiological Diagnosis (PhD)All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled. | Device | CRT Therapy |
Primary outcome
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
Time frame: Thirteen months
Mean number of false positives per patient per year.
Time frame: Thirteen 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 15 May 2014.
- Background: PubMed 20947571Auricchio A, Brugada J, Ellenbogen KA, Gold MR, Leyva F; CLEPSYDRA investigators. Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study. Eur J Heart Fail. 2010 Dec;12(12):1363-71. doi: 10.1093/eurjhf/hfq170. Epub 2010 Oct 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paradym CRT + Physiological Diagnosis (PhD) in people with Congestive Heart Failure, run by ELA Medical, Inc. at 1 site in United States.
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 15 May 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee). (time frame: Thirteen months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957541, which also lists 1 linked publication.
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 15 May 2014.