Heart FailurePhase 4NCT00658203
Clinical Evaluation on Advanced Resynchronization
A Phase 4 study testing New Living CHF in people with Heart Failure and Cardiomyopathy, run by LivaNova at 36 sites in 6 countries.
Trial summary
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy
- What is being tested?
- New Living CHF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 36 sitesin 6 countries
- Study dates
- Nov 2005to Feb 2008
- 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
- The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:
- Severe Heart Failure (NYHA Class III or IV)
- Cardiomyopathy of any etiology
- Sinus rhythm
- Reduced Left-Ventricular Ejection Fraction
- Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD>30 mm/m2)
Show all 13Show fewer
- QRS Duration:
- > 150 ms or
- > 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:
- Aortic Pre-Ejection Delay > 140 ms
- Interventricular Mechanical Delay > 40 ms
- Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)
- Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics
Who cannot join
- Any patient who has one of the following characteristics will be excluded from the study:
- ICD indication (Life-threatening ventricular arrhythmias)
- Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
- Patient already implanted with a conventional pacemaker device
- Myocardial infarction within the last three months
- Heart surgery, or revascularization within the last three months, or expected
Show all 15Show fewer
- Heart surgery refused because of co-morbidity factors
- Included in transplantation list
- Already enrolled in other study
- Life expectancy less than 1 year
- Pregnancy
- Age less than 18
- Forfeiture of freedom or under guardianship
- Not able to understand the aim of the study and its procedures
- Refusing to cooperate
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
France12 sites
CH Albi
Albi
CHU Angers
Angers
CHU Bordeaux
Bordeaux
CH Lomme
Lomme
CHU Montpellier
Montpellier
NC Nantaises
Nantes
CH Pau
Pau
CHU Poitiers
Poitiers
CHR Cardiologie A
Rennes
CHU Rouen
Rouen
CH Yves le Foll
Saint-Brieuc
InParys Cardiology
Saint-Cloud
Italy7 sites
Osp. B. Ramazzini
Carpi
Osp. Civile
Desio
Osp. S. Maria Nuova
Florence
Osp. Univ. Careggi
Florence
Osp. Niguarda
Milan
Osp. Civile
Rieti
Osp. S. Filippo Neri
Rome
United Kingdom5 sites
Royal Hospital
Bournemouth
Saint Peter's Hospital
Chertsey
General Hospital
Eastbourne
Nothern General
Sheffield
University Hospital
Southampton
Germany4 sites
UKB Unfallkrankenhaus
Berlin
Univ Saarland
Homburg
Stiftsklinikum Augustinum
München
St.Adolfstift
Reinbek
Netherlands4 sites
Medisch Centrum Rijnmond-Zuid
Rotterdam
Diaconessenhuis
Utrecht
Vlietland Ziekenhuis
Vlaardingen
Isala Klinieken
Zwolle
Spain4 sites
H. General Universit.
Alicante
H. Virgen de las Nieves
Granada
H. General Universit.
Valencia
Hosp. Clinico
Valencia
About this study
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.
Read the detailed description
The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms.
The objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT).
The patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005).
All patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation.
- Conditions
- Heart Failure, Cardiomyopathy
- Being tested
- New Living CHF
- Keywords
- CRT-P, PEA, Severe Heart Failure (NYHA Class III or IV), Cardiomyopathy of any etiology, Sinus rhythm, Reduced Left-Ventricular Ejection Fraction, LVEDD>30 mm/m2, QRS Duration: > 150 ms or > 120 ms, Aortic Pre-Ejection Delay > 140 ms, Interventricular Mechanical Delay > 40 ms, Delayed activation of postero-lateral Left Ventricular wall, Optimal and stable pharmacological treatment
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Living CHFDevice
PEA CRT optimization
New Living CHFDevice
Standard optimized CRT.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PEA optimized CRT Receives: Device: New Living CHF |
| 2 | Other | Standard optimized CRT Receives: Device: New Living CHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation.
Measured: 12 months
Secondary outcomes (21)
PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.
Measured: 12 months
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of NYHA
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of BNP dosage
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Number and duration of heart-failure-related patient's hospitalisations, during the study period.
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of E velocity
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of A velocity
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
Measured: 12 months
Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
Measured: 12 months
Time spent to achieve the CRT optimal configuration during each follow-up
Measured: 12 months
PEA monitoring and prognostic relevance correlating the PEA diagnostic trends with the parameters used to asses the efficacy of the therapy and patients' quality of life (NYHA class, mortality, HF-hospitalisation, EuroQoL-5D score, BNP dosage, Echo
Measured: 12 months
(LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startNov 2005
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P Ritter, Dr, Principal investigator, InParys Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658203
- Sponsor's protocol ID
- CLEAR - IPEA01
- Status last verified
- Apr 2008
- First submitted
- 28 Mar 2008
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation on Advanced Resynchronization
- ClinicalTrials.gov ID
- NCT00658203
- Acronym / sponsor ID
- CLEAR - IPEA01
- Conditions
- Heart Failure, Cardiomyopathy
- Keywords
- CRT-P, PEA, Severe Heart Failure (NYHA Class III or IV), Cardiomyopathy of any etiology, Sinus rhythm, Reduced Left-Ventricular Ejection Fraction, LVEDD>30 mm/m2, QRS Duration: > 150 ms or > 120 ms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Apr 2008 (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 aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.
Detailed description
The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms.
The objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT).
The patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005).
All patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: New Living CHFPEA optimized CRT |
| 2 | Other | Device: New Living CHFStandard optimized CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:
- Severe Heart Failure (NYHA Class III or IV)
- Cardiomyopathy of any etiology
- Sinus rhythm
- Reduced Left-Ventricular Ejection Fraction
Key exclusion criteria (15 listed)
- ICD indication (Life-threatening ventricular arrhythmias)
- Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
- Patient already implanted with a conventional pacemaker device
- Myocardial infarction within the last three months
- Heart surgery, or revascularization within the last three months, or expected
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 |
|---|---|---|
| New Living CHFPEA CRT optimization | Device | 1 |
| New Living CHFStandard optimized CRT. | Device | 2 |
Primary outcome
The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation.
Time frame: 12 months
21 secondary outcomes
PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.
Time frame: 12 months
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of NYHA
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of BNP dosage
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Number and duration of heart-failure-related patient's hospitalisations, during the study period.
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of E velocity
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of A velocity
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
Time frame: 12 months
Time spent to achieve the CRT optimal configuration during each follow-up
Time frame: 12 months
PEA monitoring and prognostic relevance correlating the PEA diagnostic trends with the parameters used to asses the efficacy of the therapy and patients' quality of life (NYHA class, mortality, HF-hospitalisation, EuroQoL-5D score, BNP dosage, Echo
Time frame: 12 months
(LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.
Time frame: 6 and 12 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 14 Apr 2008.
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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.
P Ritter, Dr principal investigator
InParys Cardiologie
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing New Living CHF in people with Heart Failure and Cardiomyopathy, run by LivaNova at 36 sites in 6 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 13 inclusion and 15 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 14 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Italy, United Kingdom, Germany, Netherlands and 1 more country. 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 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?
The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation. (time frame: 12 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 14 Apr 2008.